298. 遺伝性膵炎
[臨床試験数:93,薬物数:168(DrugBank:51),標的遺伝子数:48,標的パスウェイ数:134

Searched query = "Hereditary pancreatitis", "Chronic pancreatitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04315311
(ClinicalTrials.gov)
December 31, 202018/3/2020Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerA Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerExocrine Pancreatic Insufficiency (EPI)Drug: CREONAbbVieNULLNot yet recruiting18 YearsN/AAll50Phase 4United States
2NCT04611958
(ClinicalTrials.gov)
December 1, 202027/10/2020Intraductal Liposomal Bupivacaine for Chronic PancreatitisIntraductal Liposomal Bupivacaine as a Therapeutic Trial to Determine the Contribution of Peripheral Versus Central Sensitization in the Pathogenesis of Pain in Chronic Pancreatitis- a Pilot and Feasibility StudyChronic PancreatitisDrug: ERCP with Bupivacaine infusionJohns Hopkins UniversityNULLNot yet recruiting18 Years80 YearsAll8Early Phase 1United States
3ChiCTR2000037002
2020-10-012020-08-26Differential diagnosis of pancreatic cancer and chronic pancreatitis with serum miR-25A prospective study of serum miR-25 detection in differential diagnosis of pancreatic cancer and chronic pancreatitis pancreatic cancerGold Standard:Pancreatic cancer: pancreatic ductal adenocarcinoma originating from pancreatic ductal epithelium was confirmed by pathological examination (operative biopsy, puncture biopsy, cytological examination). Chronic pancreatitis: Clinically diagnosed as chronic pancreatitis, and no evidence to support the diagnosis of pancreatic cancer.;Index test:Serum miR-25;The First Affiliated Hospital of the Naval Medical University of the Chinese People's Liberation ArmyNULLPending1875BothTarget condition:150;Difficult condition:150China
4NCT04207060
(ClinicalTrials.gov)
July 15, 202017/12/2019Trial of Indomethacin in Chronic PancreatitisPhase 1/2 Trial of Indomethacin in Chronic Pancreatitis (The PAIR Trial)Chronic PancreatitisDrug: Indomethacin;Drug: PlacebosMayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting18 Years60 YearsAll32Phase 2United States
5NCT03568630
(ClinicalTrials.gov)
July 26, 201813/6/2018Blood Markers of Early Pancreas CancerA Longitudinal Cohort Study to Identify Clinical and Blood Markers of Early Pancreas CancerDiabetes Mellitus, Type 2;PreDiabetes;Pancreas Cyst;Chronic Pancreatitis;Genetic Predisposition to Disease;Inherited DiseaseDiagnostic Test: Mixed Meal Tolerance Test;Diagnostic Test: Hemoglobin A1c;Diagnostic Test: Other exploratory blood biomarkersUniversity of NebraskaNational Cancer Institute (NCI);Virginia Mason Hospital/Medical Center;VA Nebraska Western Iowa Health Care SystemRecruiting19 YearsN/AAll1250United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-UMIN000030735
2018/01/1515/01/2018Diagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary diseaseDiagnostic accuracy of contrast enhanced endoscopic ultrasonography in pancreatbiliary disease - A clinical trial of contrast enhanced endoscopic ultrasonography in the pancreatobiliary disease Pancreas tumor, Chronic pancreatitis, Autoimmune pancreatitis, Gallblader polyp, Biliary tract tumorContrast enhanced endoscopic ultrasonography using perflubutane
MRI
enhanced CT
endoscopic ultrasonography without perflubutane
Department of EndoscopyThe Jikei University School of MedicineNULLComplete: follow-up complete20years-old100years-oldMale and Female786Not selectedJapan
7NCT03283566
(ClinicalTrials.gov)
October 3, 201713/9/2017Hydroxychloroquine and Metabolic Outcomes in Patients Undergoing TPAITHydroxychloroquine and Metabolic Outcomes in Patients Undergoing Total Pancreatectomy and Autologous Islet Transplantation: A Clinical, Molecular, and Genomic StudyChronic Pancreatitis;Insulin Dependent DiabetesDrug: Hydroxychloroquine;Drug: PlaceboThe Cleveland ClinicAllegheny Singer Research Institute (also known as Allegheny Health Network Research Institute);Stanford UniversityCompleted18 Years65 YearsAll9Phase 2United States
8NCT03244683
(ClinicalTrials.gov)
August 28, 20177/8/2017A Study of the Efficacy of ONS to Reduce Postoperative Complications Associated With Pancreatic SurgeryA Study of the Efficacy of Oral Nutritional Supplementation to Reduce Postoperative Complications Associated With Pancreatic SurgeryPancreatic Cancer;Chronic PancreatitisDietary Supplement: Ensure Surgical;Other: Nutrition counseling;Other: Low-intensity exercise therapyOhio State UniversityAbbott NutritionActive, not recruiting40 Years89 YearsAll150N/AUnited States
9JPRN-UMIN000028150
2017/07/1010/07/2017Analysis of apolipoprotein A2 isoform as a novel pancreatic exocrine marker Healthy volunteers, patients with chronic pancreatitis, patients with chronic hepatitisBlood test and PFD testYokohama City UniversityNULLRecruiting20years-old75years-oldMale and Female200Not selectedJapan
10EUCTR2017-000732-34-DK
(EUCTR)
21/06/201725/04/2017Drug Release and Absorption from Controlled Release Formulations in Patients with Gastrointestinal Dysfunctions.Oral Controlled Release Formulations to Patients with Gastrointestinal Dysfunction – Is the Release of Drug and the Absorption Impaired? - ABOXY Healthy (pain) and patients (pain).
MedDRA version: 20.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis;System Organ Class: 100000004856
MedDRA version: 20.0;Classification code 10012594;Term: Diabetes;System Organ Class: 100000004861
MedDRA version: 20.0;Classification code 10048516;Term: Gastrointestinal disorder (NOS);Classification code 10050554;Term: Gastric bypass NOS;System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Mech-Sense, Dept. Gastroenterology & Hepatology, Aalborg University HospitalNULLNot Recruiting Female: yes
Male: yes
135Phase 1;Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT03481803
(ClinicalTrials.gov)
January 27, 20176/3/2018A Phase IIa Study With Escalating Dose of MS1819-SDA Multicentre Open-label Phase IIa Study With Escalating Dose of MS1819- SD, to Investigate the Efficacy and Safety of a Yarrowia Lipolytica Lipase Preparation for the Compensation of Exocrine Pancreatic Insufficiency Caused by Chronic Pancreatitis and/or Distal PancreatectomyChronic Pancreatitis;Distal PancreatectomyDrug: MS1819-SDAzurRx SASNULLCompleted18 YearsN/AAll11Phase 2Australia;France;New Zealand
12NCT02713997
(ClinicalTrials.gov)
December 201629/2/2016Anti-inflammatory Therapy to Improve Outcomes After TPIATAnti-inflammatory Therapy to Improve Outcomes in Patients With Chronic Pancreatitis Undergoing Total Pancreatectomy Islet AutotransplantationPancreatitis, Chronic; Diabetes; TransplantDrug: etanercept;Drug: Alpha 1-AntitrypsinUniversity of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting18 Years65 YearsAll45Phase 4United States
13NCT02971475
(ClinicalTrials.gov)
November 20165/9/2016ESWL Versus ESWL and Endoscopic TreatmentExtracorporeal Shock Wave Lithotripsy Versus Extracorporeal Shock Wave Lithotripsy Combined With Endoscopic Treatment for Painful Calcified Chronic PancreatitisPancreatitisProcedure: extracorporeal shock wave lithotripsy;Procedure: endoscopic drainage of the main pancreatic duct;Drug: AnalgesicsChanghai HospitalNULLUnknown status18 YearsN/AAll62N/AChina
14NCT02849704
(ClinicalTrials.gov)
October 13, 201627/7/2016Fat Malabsorption in Chronic PancreatitisDiagnosing Pancreatic-Based Malabsorption in Patients With Chronic PancreatitisChronic PancreatitisDrug: Creon36™Children's Hospital of PhiladelphiaAbbVie;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Phoenix Indian Medical CenterCompleted30 Years70 YearsAll48Phase 2United States
15NCT02947087
(ClinicalTrials.gov)
October 201618/10/2016Alpha-1 Antitrypsin (AAT) Enhances Islet Autograft Survival in Patients With Chronic PancreatitisAlpha-1 Antitrypsin (AAT) Enhances Islet Autograft SurvivalChronic PancreatitisDrug: Prolastin-C;Drug: PlaceboMedical University of South CarolinaNULLRecruiting18 YearsN/AAll48Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02743364
(ClinicalTrials.gov)
September 19, 201615/4/2016Simvastatin in Reducing Pancreatitis in Patients With Recurrent, Acute or Chronic PancreatitisStatin Therapy to Reduce the Risk of Recurrent PancreatitisAcute PancreatitisOther: Laboratory Biomarker Analysis;Other: Placebo Administration;Other: Quality-of-Life Assessment;Other: Questionnaire Administration;Drug: SimvastatinNational Cancer Institute (NCI)NULLActive, not recruiting18 YearsN/AAll8Phase 2United States
17NCT02965898
(ClinicalTrials.gov)
September 201623/9/2016The Effect of Vitamin D Substitution on the Development of Chronic PancreatitisThe Effect of Vitamin D Substitution on Pancreatic Parenchyma and Development of Fibrosis After First Acute Alcoholic Pancreatitis: A Randomized Prospective TrialChronic PancreatitisDietary Supplement: Vitamin D 100ug;Dietary Supplement: Vitamin D 10ugTampere University HospitalOrion Corporation, Orion PharmaRecruiting18 Years101 YearsAll260N/AFinland
18NCT02869893
(ClinicalTrials.gov)
August 10, 20165/6/2016MRCP: A Reliable, Non Invasive Method for Staging Chronic Pancreatitis in PediatricsMagnetic Resonance Cholangiopancreatography (MRCP): A Reliable, Non Invasive Method for Staging Chronic Pancreatitis From Minimal Change Disease to the Advanced Stages in PediatricsHealthy VolunteersDrug: SecretinChildren's Hospital Medical Center, CincinnatiChiRhoClin, Inc.;The National Pancreas FoundationCompleted6 Years15 YearsAll57N/AUnited States
19NCT02706236
(ClinicalTrials.gov)
April 201627/2/2016Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic PancreatitisA Single-Center Prospective Randomized Placebo Controlled Trial of Pancreatic Enzyme Supplements (Pancrelipase) for Treating Pain in Patients With Chronic PancreatitisPancreatitisDrug: Pancrelipase;Drug: placeboDartmouth-Hitchcock Medical CenterNULLWithdrawn18 YearsN/AAll0Phase 2United States
20EUCTR2015-002570-20-ES
(EUCTR)
25/02/201618/04/2016Optimizing treatment of maldigestion in patients with chronic pancreatitisOpen label, randomized, crossover clinical trial to evaluate the efficacy of increasing doses of pancreatic enzymes against inhibition of acid gastric secretion in patients with exocrine pancreatic insufficiency secondary to chronic pancreatitis Patients diagnosed of chronic pancreatitis with pancreatic exocrine insufficiency under pancreatic enzyme replacement therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]Trade Name: Kreon 25000
Product Name: Creon 25000
Product Code: PL 00512/0150
Department of gastroenterology. University Hospital of SantiagoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT02693093
(ClinicalTrials.gov)
December 201512/2/2016A Dose Ranging Study Evaluating Efficacy and Safety of NI-03A Phase 1, Single Dose PK and Safety Study With NI-03 Followed by a Phase 2, Randomized, Double-Blind, Parallel-Group Dose-Ranging Study to Evaluate the Safety and Efficacy of NI-03 When Compared to Placebo in Subjects With Chronic PancreatitisChronic PancreatitisDrug: NI-03;Drug: PlaceboKangen Pharmaceuticals, IncNULLRecruiting18 Years85 YearsAll260Phase 1;Phase 2United States;Russian Federation;Ukraine
22NCT02538146
(ClinicalTrials.gov)
August 201526/8/2015Effect of Acetyl-L-carnitine on Chronic PancreatitisAcetyl-L-carnitine as Pain Therapy in Chronic PancreatitisChronic PancreatitisDietary Supplement: acetyl-L-carnitine 1000mg 2X per day for 3 monthsKarin HighUniversity of KentuckyTerminated20 Years90 YearsAll3Early Phase 1United States
23NCT02577640
(ClinicalTrials.gov)
July 20157/10/2015Dietary Soy Isoflavones In Chronic PancreatitisDietary Soy Isoflavones In Chronic PancreatitisChronic PancreatitisDietary Supplement: Soy breadOhio State UniversityNULLCompleted18 YearsN/AAll11N/AUnited States
24NCT02487225
(ClinicalTrials.gov)
May 201529/6/2015Pentoxifylline Treatment in Acute Pancreatitis (AP)Pentoxifylline Treatment in Acute Pancreatitis: A Double-Blind Placebo - Controlled Randomized TrialAcute Pancreatitis (AP);Gallstone Pancreatitis;Alcoholic Pancreatitis;Trauma Acute Pancreatitis;Hypertriglyceridemia Acute Pancreatitis;Idiopathic (Unknown) Acute Pancreatitis;Medication Induced Acute Pancreatitis;Cancer Acute Pancreatitis;Miscellaneous (i.e. Acute on Chronic Pancreatitis)Drug: Pentoxifylline;Drug: PlaceboMayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed18 Years100 YearsAll83Phase 3United States
25NCT02567240
(ClinicalTrials.gov)
January 20151/10/2015Carbon Monoxide-Saturated Medium for Islet IsolationA Novel Approach to Harvest Islets for Autologous Islet TransplantationChronic PancreatitisOther: Carbon monoxide-bubbled mediumsMedical University of South CarolinaNULLCompleted18 Years69 YearsAll16Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02399800
(ClinicalTrials.gov)
December 201411/1/2015Celiac Plexus Block for Chronic Pancreatitis RCTProspective Randomized Trial of EUS Guided Celiac Plexus Block for Chronic PancreatitisPancreatitis, Chronic;PancreatitisProcedure: Celiac Block with triamcinolone and bupivicaine;Procedure: No Celiac Block;Drug: Intra Plexus Triamcinolone and Bupivicaine InjectionUniversity of Southern CaliforniaNULLTerminated18 YearsN/AAll1N/AUnited States
27NCT02384018
(ClinicalTrials.gov)
December 201416/12/2014Mesenchymal Stem Cell and Islet Co-transplantationA Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow-derived Mesenchymal Stromal Cells in Chronic Pancreatitis Patients Who Undergo Total Pancreatectomy and Islet Autotransplantation.Chronic Pancreatitis;DiabetesBiological: autologous mesenchymal stromal cellMedical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting18 Years69 YearsAll24Phase 1United States
28NCT01967888
(ClinicalTrials.gov)
February 201418/10/2013Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantationA Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Assignment Study to Assess the Efficacy and Safety of Reparixin in Pancreatic Islet Auto-transplantationPancreatectomy for Chronic PancreatitisDrug: Reparixin;Drug: PlaceboDompé Farmaceutici S.p.ANULLCompleted18 YearsN/AAll104Phase 2;Phase 3United States;Canada
29EUCTR2013-003357-17-DK
(EUCTR)
01/11/201304/11/2013The Ketamine - a novel approach to treating painful chronic pancreatitis.RESET TrialA randomized, double-blinded, single-centre, parallel-group, placebo-controlled, prospective trial of S-ketamine for pain treatment in chronic pancreatitis (RESET trial) - RESET Trial Chronic Pancreatitis
MedDRA version: 17.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis;System Organ Class: 100000004856
MedDRA version: 17.1;Level: HLT;Classification code 10033646;Term: Acute and chronic pancreatitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: S-Ketamin
Product Name: S-ketamin
Trade Name: Midazolam
Product Name: Midazolam
Prof. Asbjørn Mohr DrewesNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Denmark
30JPRN-UMIN000013182
2013/10/1618/02/2014Efficacy of the pancrelipase for early chronic pancreatitis early chronic pancreatitisPancrelipase
no treatment
Fukushima Medical University Aizu Medical CenterNULLRecruitingNot applicableNot applicableMale and Female60Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2012-004170-26-IT
(EUCTR)
04/12/201211/10/2012Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis.Randomized double blinde placebo controlled trial to evaluate the efficacy of N-acetylcystein in patients with chronic pancreatitis and primary sclerosing cholangitis. Chronic pancreatitis and primary sclerosing cholangitis
MedDRA version: 15.0;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 15.0;Classification code 10008609;Term: Cholangitis sclerosing;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: FLUIMUCIL*20CPR EFF 600MG
INN or Proposed INN: ACETYLCYSTEINE
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
200Italy
32NCT01551511
(ClinicalTrials.gov)
October 20127/2/2012?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel DesignPancreatitis, Chronic;Abdominal Pain;Chronic PainDrug: Tetrahydrocannabinol;Drug: PlaceboRadboud UniversityEuropean UnionCompleted18 YearsN/ABoth29Phase 2Netherlands
33EUCTR2012-000730-19-NL
(EUCTR)
23/08/201212/03/2012?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal PainThe analgesic efficacy of ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal Pain: a Randomized, Double-blinded, Placebo-controlled, Parallel Design - Delta-Pain II Chronic pancreatitis with persistant abdominal pain
MedDRA version: 14.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Product Name: Namisol
Product Code: A04AD10
INN or Proposed INN: DRONABINOL
Other descriptive name: Tetrahydro-6,6,9-tri methyl-3-penthyl-6 H-dibenzo[ b,d ]pyran-1-ol
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: yes
Male: yes
68Phase 2Netherlands
34JPRN-UMIN000008340
2012/08/0104/07/2012pancreatic exocrine function with non-contrast MRI:Visualization by Means of MRCP with Spatially Selective Inversion-Recovery Pulse Chronic pancreatitisMRCP/PFD test
MRCP
the Department of Diagnostic Radiology Kawasaki Medical SchoolNULLComplete: follow-up completeNot applicableNot applicableMale and Female40Not selectedJapan
35JPRN-UMIN000009547
2012/08/0101/01/2013Prospectivestudy on the treatment effect of pancrelipase on chronic pancreatitis patient's alubumin concentration Chronic pancreatitis600mg of Pancrelipase (granules or capsels) to be taken three times a day (1800mg /day) after meals for 4 weeks.Department of Internal Medicine Second Teaching Hospital Fujita Health University School of MedicineNULLRecruiting20years-oldNot applicableMale and Female83Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT02458118
(ClinicalTrials.gov)
June 201227/5/2015Pancreatic Perfusion Using Secretin and MRIStudy to Assess Pancreatic Blood Flow at Rest and During Stimulation Using Magnetic Resonance Imaging (fMRI) in Patients With Chronic PancreatitisChronic PancreatitisDrug: SecretinUniversity of NottinghamNULLRecruiting18 Years80 YearsBoth15Phase 1;Phase 2United Kingdom
37NCT01528540
(ClinicalTrials.gov)
April 201227/1/2012Evaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a Randomized Control TrialEvaluation of Efficacy of Combination of Pregabalin and Antioxidant in Reducing Pain in Chronic Pancreatitis: a RCTChronic PancreatitisDrug: Placebo;Drug: Antioxidant plus PregabalinAsian Institute of Gastroenterology, IndiaNULLCompleted18 Years65 YearsBoth87N/AIndia
38NCT01318590
(ClinicalTrials.gov)
November 18, 201117/3/2011Prospective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic PancreatitisProspective Study on Endoscopic Ultrasound (EUS) Celiac Bloc Efficacy in Chronic PancreatitisPancreatitis, ChronicDrug: EUS procedure with drug injection;Other: EUS procedureCentre hospitalier de l'Université de Montréal (CHUM)Centre de Recherche du Centre Hospitalier de l'Université de Montréal;Erasme University HospitalTerminated18 YearsN/AAll2Phase 3Belgium;Canada
39NCT01430234
(ClinicalTrials.gov)
October 20111/9/2011Enzyme Suppletion in Exocrine Pancreatic DysfunctionEnzyme Substitution in Exocrine Pancreatic Insufficiency; Self Administration Against a Fixed Dose RegimenChronic Pancreatitis;Exocrine Pancreatic InsufficiencyDrug: Panzytrat 25.000 FIP-E units of LipaseFoundation for Liver ResearchAxcan PharmaCompleted18 Years90 YearsBoth10Phase 4Netherlands
40NCT01318369
(ClinicalTrials.gov)
October 20119/3/2011Efficacy Study of ?9-THC to Treat Chronic Abdominal PainThe Safety, Tolerability, and Analgesic Efficacy of ?9-THC (Namisol®) in Chronic Pancreatitis Patients Suffering From Persistent Abdominal PainCannabinoid;Tetrahydrocannabinol;Chronic Pancreatitis;Abdominal PainDrug: Namisol;Drug: DiazepamRadboud UniversityNULLCompleted18 YearsN/ABoth24Phase 2Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2010-020303-69-NL
(EUCTR)
19/09/201119/09/2011Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPESEnzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES Exocrine pancreatic insufficiency in patients with chronic pancreatitis
MedDRA version: 12.1;Level: LLT;Classification code 10041969;Term: Steatorrhoea
Trade Name: Panzytrat
Product Name: Panzytrat
Product Code: RVG 13760
INN or Proposed INN: pancreatic enzymes
Other descriptive name: LIPASE
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Netherlands
42EUCTR2011-000647-24-NL
(EUCTR)
26/07/201112/05/2011Efficacy study of ?9-THC to treat persistent abdominal pain as a result of chronic pancreas inflammationThe safety, tolerability, and analgesic efficacy of ?9-THC (Namisol®) in chronic pancreatitis patients suffering from persistent abdominal pain - ?9-THC in chronic pain patients with abdominal pain as a result of chronic pancreatitis
MedDRA version: 13.1;Level: PT;Classification code 10033649;Term: Pancreatitis chronic;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Namisol
Product Code: A04AD10
INN or Proposed INN: DRONABINOL
Radboud University Nijmegen Medical CentreNULLNot RecruitingFemale: no
Male: yes
Netherlands
43NCT04574297
(ClinicalTrials.gov)
January 1, 201127/9/2020An Observational Study on the Natural Course of Chronic PancreatitisThe Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis:An Observational StudyChronic Pancreatitis;Genetic Mutation;Smoking, Tobacco;Drinking, AlcoholBehavioral: smoking and alcohol assumption;Diagnostic Test: genetic sequencingChanghai HospitalNULLActive, not recruitingN/AN/AAll965NULL
44NCT01265875
(ClinicalTrials.gov)
December 201022/12/2010Secretin Infusion for Pain Due to Chronic PancreatitisSecretin Infusion for Pain Due to Chronic PancreatitisChronic PancreatitisDrug: Human SecretinChiRhoClin, Inc.Dartmouth-Hitchcock Medical CenterCompleted18 Years70 YearsAll12Phase 1;Phase 2United States
45NCT01146561
(ClinicalTrials.gov)
October 13, 201024/5/2010Safety And Efficacy Of Tanezumab In Patients With Chronic PancreatitisA PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITISChronic PancreatitisBiological: Tanezumab;Other: PlaceboPfizerNULLTerminated18 Years99 YearsAll2Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT01452217
(ClinicalTrials.gov)
September 201010/10/2011Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy VolunteersThe Use of Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy VolunteersChronic PancreatitisDrug: SecretinUniversity of NottinghamNULLCompleted18 Years75 YearsMale12Phase 1United Kingdom
47NCT01159119
(ClinicalTrials.gov)
August 2, 20105/7/2010A Study of EUR-1066 in Subjects With Chronic Pancreatitis, Exocrine Pancreatic Insufficiency and Chronic Abdominal PainSingle Center Randomized Single Blind Crossover Group Active Control Study to Evaluate Safety and Efficacy of EUR-1066 a Pancreatic Enzyme Product in Patients With Chronic Pancreatitis Exocrine Pancratic Insufficiency,Chronic Abdominal PainChronic PancreatitisDrug: EUR-1066-A;Drug: Zenpep;Drug: EUR-1066-BForest LaboratoriesUniversity of FloridaTerminated18 YearsN/AAll15Phase 1United States
48NCT01236053
(ClinicalTrials.gov)
June 201014/10/2010Cancer in Patients With Gabapentin (GPRD)Risk of Cancer in Patients Exposed to Gabapentin in the GPRDPain, Neuropathic;Epilepsy;Renal Pelvis Cancer;Pancreatic Cancer;Breast Cancer;Nervous System Cancer;Chronic Pancreatitis;Stomach Cancer;Renal Cell Carcinoma;Diabetes;Bladder Cancer;Bone and Joint Cancer;Penis Cancer;Anal Cancer;Cancer;Renal CancerDrug: Gabapentin prescriptionsGlaxoSmithKlineNULLCompletedN/AN/AAll2323608N/ANULL
49EUCTR2010-018900-10-FR
(EUCTR)
11/05/201019/03/2010Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitisSafety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis Exocrine pancreatic insufficiency resulting from chronic pancreatitis
MedDRA version: 12.1;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency
Product Name: MS1819
Product Code: MS1819
INN or Proposed INN: Yarrowia lipolytica lipase
Laboratoires Mayoly SpindlerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12France
50EUCTR2005-000562-38-DE
(EUCTR)
20/04/201029/09/2005RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002 The purpose of this trial is to evaluate the clinical efficacy and safety of a gastro-resistant film-coated tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 7.0;Level: LLT;Classification code 10033628
Trade Name: Mezym F
Product Name: Mezym F
Product Code: Pancreatin
INN or Proposed INN: Pancreatin
Berlin-Chemie AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2009-016082-29-BE
(EUCTR)
10/03/201025/11/2009Role of Lanreotide in the Management of Paraduodenal Pancreatitis - LPPRole of Lanreotide in the Management of Paraduodenal Pancreatitis - LPP Paraduodenal pancreatitis
MedDRA version: 12.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Trade Name: Somatuline Autogel 90 mg
Other descriptive name: LANREOTIDE ACETATE
Erasme hospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Belgium
52NCT01138124
(ClinicalTrials.gov)
March 20103/6/2010Gabapentin and Risk of Pancreatic Cancer and Renal Cancer (GPRD)Risk of Pancreatic Cancer and Renal Cancer in Patients Exposed to Gabapentin in the United Kingdom General Practice Research DatabaseRenal Pelvis Cancer;Restless Legs Syndrome;Epilepsy;Neuropathic Pain;Chronic Pancreatitis;Hypertension;Pancreatic Cancer;Diabetes;Renal Cancer;Renal Cell CarcinomaDrug: Gabapentin prescriptionsGlaxoSmithKlineNULLCompletedN/AN/AAll54202N/ANULL
53JPRN-UMIN000003020
2010/01/0113/01/2010Establishment of pancreatic exocrine function assaay usin real time 13C breath test. Chronic pancreatitis, state after pancreatectomyExpiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in healthy volunteers.
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in patients after total pancreatectomy.
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in patients after pancreatico duodenectomy.
Expiratory 13CO2 measurement after oral intake of 13C incorporated fatty acids and amino acids in patients with chronic pancreatits.
Tohoku University HospitalNULLRecruiting20years-old80years-oldMale and Female8Not applicableJapan
54NCT01141998
(ClinicalTrials.gov)
December 200910/6/2010Vitamin D Substitution for Patients With Chronic Pancreatitis and MalabsorptionVitamin D Substitution for Patients With Chronic Pancreatitis and MalabsorptionChronic Pancreatitis;Malabsorption SyndromesDrug: Calcium, Dietary;Drug: Cholecalciferol;Radiation: UVB;Radiation: UV-filtered light.Hvidovre University HospitalNULLCompleted18 YearsN/ABoth27N/ADenmark
55NCT01001923
(ClinicalTrials.gov)
December 200926/10/2009Single Injection of REGN475/SAR164877 in the Treatment of Chronic Pancreatitis PainRandomized, Double-blind, Placebo-controlled Study of the Effect of a Single Injection of SAR164877 (REGN475) on Reduction of Pain From Chronic PancreatitisAbdominal Pain UpperDrug: REGN475/SAR164877;Drug: Placebo (for REGN475/SAR164877)Regeneron PharmaceuticalsNULLTerminated18 Years80 YearsBoth15Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2009-010266-28-NL
(EUCTR)
21/07/200929/01/2009Een gerandomiseerde dubbelblinde, placebogecontroleerde, klinische parallelle groep studie van pregabaline in patiënten met chronische pancreatitis - Effect van pregabaline therapie bij patiënten met chronische pancreatitisEen gerandomiseerde dubbelblinde, placebogecontroleerde, klinische parallelle groep studie van pregabaline in patiënten met chronische pancreatitis - Effect van pregabaline therapie bij patiënten met chronische pancreatitis chronische pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Trade Name: Lyrica® Afdeling heelkunde, Universitair Medisch Centrum Sint RadboudNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Netherlands
57NCT01142128
(ClinicalTrials.gov)
February 20099/6/2010Viokase 16, Viokase16 Plus Nexium and Nexium AloneA Randomized, Single Site, Double Blind, Fixed Dose, Cross Over Study of Viokase 16, Viokase16 Plus Nexium and Nexium Alone in the Reduction of Abdominal Pain in Patients With Chronic PancreatitisChronic PancreatitisDrug: Nexium (esomeprazole magnesium);Drug: Placebo to Nexium;Drug: Viokase 16 (pancrelipase) + Nexium;Drug: Viokase 16 + placebo to NexiumUniversity of FloridaAstraZenecaTerminated18 Years75 YearsAll12Phase 1United States
58NCT01259544
(ClinicalTrials.gov)
January 200912/12/2010BreathID® Test: A Non-invasive Modality to Detect Pancreatic Exocrine InsufficiencyChronic Pancreatitis;Healthy VolunteersDrug: benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)Exalenz Bioscience LTD.Virginia Commonwealth University;Asian Institute of Gastroenterology, Hyderabad, IndiaCompleted18 YearsN/ABoth33Phase 2India
59EUCTR2006-000087-83-GB
(EUCTR)
19/12/200804/12/2007EUROPAC2 trial to investigate the efficacy of ANTOX(vers) 1.2 and MGCT (magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis. - EUROPAC2EUROPAC2 trial to investigate the efficacy of ANTOX(vers) 1.2 and MGCT (magnesiocard) for the treatment of hereditary pancreatitis and idiopathic chronic pancreatitis. - EUROPAC2 Hereditary Pancreatitis and Idiopathic Chronic Pancreatitis
MedDRA version: 13.1;Level: HLT;Classification code 10033646;Term: Acute and chronic pancreatitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: PT;Classification code 10056976;Term: Hereditary pancreatitis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: Magnesiocard 2.5mmol
Other descriptive name: MAGNESIUM ASPARTATE HYDROCHLORIDE
Product Name: ANTOX (vers) 1.2
Product Code: ANTOX
Other descriptive name: TOCOPHEROL
INN or Proposed INN: ASCORBIC ACID
Other descriptive name: SELENIUM
INN or Proposed INN: METHIONINE
University of LiverpoolThe Royal Liverpool and Broadgreen University Hospitals NHS TrustAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United Kingdom
60NCT00782795
(ClinicalTrials.gov)
November 200829/10/2008Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life QualityPhase II Study of Chronic Pancreatitis and the Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life QualityChronic Pancreatitis;Insulin Resistance;Normal or Mildly Abnormal Stool Fat LevelsDrug: Pioglitazone;Drug: PlaceboUniversity of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA);Takeda Pharmaceuticals North America, Inc.Completed18 Years75 YearsAll64Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT00755573
(ClinicalTrials.gov)
October 200818/9/2008Pain and Chronic Pancreatitis - Clinical End Experimental StudiesA Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical and Experimental Pilot Study of Pregabalin in Patients With Chronic PancreatitisChronic PancreatitisDrug: Pregabalin;Drug: placeboAalborg UniversitetshospitalRadboud UniversityCompleted18 Years75 YearsBoth64Phase 2;Phase 3Denmark;Netherlands
62NCT00744250
(ClinicalTrials.gov)
August 200828/8/2008Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo ControlIntraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic FibrosisDrug: PancrelipaseDigestive Care, Inc.University of North Carolina, Chapel HillTerminated18 YearsN/ABoth3Phase 4United States
63EUCTR2008-002671-27-DK
(EUCTR)
14/07/200830/05/2008A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL AND EXPERIMENTAL PILOTSTUDY OF PREGABALIN IN PATIENTS WITH CHRONIC PANCREATITISA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL AND EXPERIMENTAL PILOTSTUDY OF PREGABALIN IN PATIENTS WITH CHRONIC PANCREATITIS Chronic pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10033649;Term: Pancreatitis chronic
Trade Name: Lyrica
INN or Proposed INN: pregabalin
INN or Proposed INN: Pregabalin
Department of Medical GastroenterologyNULLNot RecruitingFemale: yes
Male: yes
45Phase 3Denmark
64NCT00401076
(ClinicalTrials.gov)
July 200816/11/2006A Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Pancreatic Exocrine InsufficiencyA One-year Open-label Study to Assess the Safety of Oral Long-term Use of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by PancreatectomyPancreatic Exocrine Insufficiency, Chronic Pancreatitis, PancreatectomyDrug: SA-001AbbottNULLCompleted20 YearsN/ABoth80Phase 3Japan
65NCT00705978
(ClinicalTrials.gov)
June 200826/6/2008Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic PancreatitisA One Week Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study With Creon 40,000 MMS in Subjects With Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis, Followed by an Open-Label Long-Term ExtensionPancreatic InsufficiencyDrug: Pancreatin;Drug: PlaceboAbbott ProductsQuintiles, DatamapCompleted18 YearsN/ABoth62Phase 3India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2007-000375-42-HU
(EUCTR)
07/04/200814/12/2007A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitisA multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis Pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Product Name: Recombinant microbial lipase
Product Code: SLV339
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
112Hungary;Czech Republic;Denmark;Latvia;Sweden
67EUCTR2008-000061-37-IT
(EUCTR)
02/04/200808/05/2008A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Safety and Efficacy of two doses of Zentase? (EUR-1008) in Chronic Pancreatitis (CP) patients with Exocrine Pancreatic Insufficiency (EPI) - PR-002 Chronic Pancreatitis (CP) with Exocrine Pancreatic Insufficiency (EPI)
MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders
Product Name: ZENTASE
INN or Proposed INN: Multienzymes (lipase, protease etc.)
EURAND SPANULLNot RecruitingFemale: yes
Male: yes
72Italy
68NCT00658736
(ClinicalTrials.gov)
March 20089/4/2008Efficacy of EUS-guided Celiac Plexus Blockade in Chronic PancreatitisA Randomized, Triple-Blinded Study of Endoscopic Ultrasound Guided Celiac Plexus Blockade (EUS-CPB) With Bupivicaine and Triamcinolone vs. Bupivicaine Alone for the Treatment of Pain in Chronic PancreatitisChronic PancreatitisDrug: Triamcinolone;Drug: Bupivicaine aloneThe Cleveland ClinicAmerican Society for Gastrointestinal Endoscopy;TAP Pharmaceutical Products Inc.Completed18 YearsN/AAll40Phase 3United States
69NCT00559052
(ClinicalTrials.gov)
March 200814/11/2007An Open-Label Study to Evaluate the Intraduodenal Delivery of Enzymes From Administration of VIOKASE16 in Exocrine Pancreatic Insufficiency (EPI)An Open-Label Cross-over Study to Evaluate the Intraduodenal Delivery of Lipase, Protease and Amylase From Administration of VIOKASE16 in Chronic Pancreatitis Subjects With Exocrine Pancreatic Insufficiency (EPI).Exocrine Pancreatic InsufficiencyDrug: VIOKASE 16Axcan PharmaAAIPharma;Mayo Clinical Services;City Hospital Laboratory BirminghamCompleted18 YearsN/ABoth22Phase 2United States;Czech Republic
70EUCTR2007-004004-12-BG
(EUCTR)
28/02/200805/02/2008A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMYA STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy
Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
52Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2007-000375-42-DK
(EUCTR)
21/02/200823/10/2007A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitisA multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis Pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Product Name: Recombinant microbial lipase
Product Code: SLV339
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
72EUCTR2007-000375-42-CZ
(EUCTR)
08/02/200817/12/2007A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitisA multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis Pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Product Name: Recombinant microbial lipase
Product Code: SLV339
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
73EUCTR2007-000375-42-LV
(EUCTR)
05/02/200812/02/2008A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitisA multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis Pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Product Name: Recombinant microbial lipase
Product Code: SLV339
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
74NCT00620919
(ClinicalTrials.gov)
February 200822/1/2008Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic PancreatitisRG1068 (Synthetic Human Secretin) Enhanced Multidetector CT Pancreatography: Evaluation of the Pancreatic Duct in Patients With Known or Suspected Chronic PancreatitisChronic PancreatitisDrug: RG1068 (Synthetic Human Secretin)Massachusetts General HospitalNULLTerminated18 Years90 YearsBoth0Phase 1United States
75NCT00621283
(ClinicalTrials.gov)
February 200822/1/2008Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric PopulationRG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric PopulationAcute Recurrent Pancreatitis;Chronic PancreatitisDrug: RG1068 (Synthetic Human Secretin)Massachusetts General HospitalNULLTerminated2 Years18 YearsBoth0Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00630279
(ClinicalTrials.gov)
February 200822/2/2008Dose-ranging Study to Evaluate Efficacy of SLV339 in Pancreatic Exocrine Insufficiency Due to Chronic PancreatitisA Multi-center, Single-blind, Parallel-design, Randomized, Placebo-controlled, Dose-ranging Study to Evaluate Oral Recombinant Microbial Lipase Efficacy in Patients With Pancreatic Exocrine Insufficiency Due to Chronic PancreatitisPancreatic Exocrine Insufficiency Due to Chronic PancreatitisDrug: Placebo;Drug: Recombinant Microbial Lipase SLV339Solvay PharmaceuticalsNULLTerminated18 YearsN/ABoth56Phase 2Czech Republic;Denmark;Hungary;Latvia;Poland;Russian Federation;Sweden
77NCT00788593
(ClinicalTrials.gov)
January 200810/11/2008A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI)A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 in Chronic Pancreatitis (CP) Patients With Exocrine Pancreatic Insufficiency (EPI)Chronic Pancreatitis;Exocrine Pancreatic InsufficiencyDrug: Placebo;Drug: EUR-1008 (APT-1008) High Dose;Drug: EUR-1008 (APT-1008) Low DoseForest LaboratoriesNULLCompleted18 YearsN/AAll82Phase 3United States;Italy;Ukraine
78EUCTR2007-000375-42-SE
(EUCTR)
21/12/200726/10/2007A multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitisA multi-center, double-blind, parallel-design, randomized,placebo-controlled, dose-ranging study to assess the efficacy andsafety of oral recombinant microbial lipase (SLV339) in subjectswith pancreatic exocrine insufficiency due to chronic pancreatitis Pancreatic exocrine insufficiency due to chronic pancreatitis
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
Product Name: Recombinant microbial lipase
Product Code: SLV339
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
80Hungary;Czech Republic;Denmark;Latvia;Sweden
79NCT00500084
(ClinicalTrials.gov)
December 200710/7/2007Phase III ALTU-135 CP Safety TrialAn Open-Label Clinical Study Evaluating the Long Term Safety of ALTU-135 in the Treatment of Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis or PancreatectomyExocrine Pancreatic InsufficiencyDrug: LiprotamaseAnthera PharmaceuticalsNULLTerminated18 YearsN/ABoth39Phase 3United States
80NCT00559364
(ClinicalTrials.gov)
November 200714/11/2007Safety and Efficacy Study of Viokase® 16 for the Correction of SteatorrheaA Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled, Phase III Study to Assess the Safety and Efficacy of Viokase® 16 for the Correction of Steatorrhea in Patients With Exocrine Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Chronic Pancreatitis;PancreatectomyDrug: Viokase® 16;Drug: Placebo;Drug: Proton pump inhibitor (PPI);Drug: OmeprazoleForest LaboratoriesNULLCompleted18 Years80 YearsAll50Phase 3United States;Canada;Poland;Slovakia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00414908
(ClinicalTrials.gov)
October 200721/12/2006A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and PancreatectomyA Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and PancreatectomyChronic Pancreatitis;Pancreatectomy;Pancreatic Exocrine InsufficiencyDrug: Pancrelipase delayed release capsule;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted18 YearsN/AAll52Phase 3United States;Bulgaria;Poland;Puerto Rico;Russian Federation;Serbia;South Africa;Ukraine;Former Serbia and Montenegro
82EUCTR2006-006958-10-GB
(EUCTR)
26/09/200701/08/2007Anticipate Trial - Randomized, Double blind, placebo-controlled, multicentre Trial of Anti-oxidant therapy in painful chronic pancreatitis. - Aniticipate trialAnticipate Trial - Randomized, Double blind, placebo-controlled, multicentre Trial of Anti-oxidant therapy in painful chronic pancreatitis. - Aniticipate trial Chronic PancreatitisProduct Name: Antox version 1.2Pharmanord, UK, LTDNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom
83NCT00400842
(ClinicalTrials.gov)
May 200716/11/2006A Study of SA-001 to Treat Pancreatic Exocrine InsufficiencyA Double-blind, Placebo-controlled, Parallel-group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by PancreatectomyExocrine Pancreatic Insufficiency, Chronic PancreatitisDrug: SA-001;Drug: PlaceboAbbottNULLCompleted20 YearsN/ABoth274Phase 3Japan
84NCT00588367
(ClinicalTrials.gov)
April 200624/12/2007CT Pancreas PerfusionCT Perfusion of Pancreatic Cancer and Chronic Pancreatitis: Feasibility StudyPancreatic Ductal Adenocarcinoma;Chronic Pancreatitis;Autoimmune PancreatitisDevice: Mayo Interactive Breath Hold MonitorMayo ClinicNULLCompleted18 YearsN/ABoth30N/AUnited States
85NCT00469703
(ClinicalTrials.gov)
August 20053/5/2007Safety and Efficacy Study of Thalomid in Patients With Chronic PancreatitisA Phase II, Open-Label, Single Center Pilot Study to Determine the Safety and Efficacy of THALOMID (Thalidomide) in Patients With Chronic Pancreatitis.Chronic PancreatitisDrug: ThalidomideWinthrop University HospitalCelgene CorporationTerminated18 Years75 YearsBoth10Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT00156403
(ClinicalTrials.gov)
August 20058/9/2005A Pilot Study of Use of Calcium Channel Blocker to Decrease Inflammation and Pain in Hereditary PancreatitisHereditary Pancreatitis Amlodipine Trial(H-PAT): A Pilot StudyPancreatitisDrug: amlodipine (drug)University of PittsburghNational Center for Research Resources (NCRR)Completed6 YearsN/ABoth8Phase 1;Phase 2United States
87EUCTR2005-000736-24-DE
(EUCTR)
14/07/200513/05/2005RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003 The purpose of this trial is to evaluate the clinical efficacy and safety of an enteric-coated pancreatin tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis.
MedDRA version: 7.0;Level: LLT;Classification code 10033628
Trade Name: Helopanflat Mono®
Product Name: Helopanflat Mono®
Product Code: Pancreatin
INN or Proposed INN: Pancreatin
Berlin-Chemie AGNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Germany
88NCT00142233
(ClinicalTrials.gov)
June 6, 200531/8/2005EUROPAC-2 - Pain Treatment of Hereditary and Idiopathic PancreatitisDouble Blind Randomised Controlled Trial to Investigate the Efficacy of ANTOX (Vers) 1.2 and MGCT (Magnesiocard) for the Treatment of Hereditary Pancreatitis and Idiopathic Chronic PancreatitisPancreatitisDietary Supplement: ANTOX (vers.)1.2;Drug: Magnesium;Other: Placebo ANTOX (vers)1.2;Other: Placebo Magnesiocard (2.5 mmol)University Medicine GreifswaldNULLCompleted5 Years75 YearsAll295Phase 3Germany
89NCT01154608
(ClinicalTrials.gov)
April 200530/6/2010Effect of Enzyme Therapy on Protein Metabolism in Chronic PancreatitisPancreatitisDrug: Creon;Other: No enzyme therapyInstitut National de la Recherche AgronomiqueNational Research Agency, France;Solvay PharmaceuticalsCompleted18 YearsN/ABoth11N/AFrance
90EUCTR2004-002468-89-DE
(EUCTR)
28/10/200423/09/2004A RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine InsufficiencyA RANDOMISED, DOUBLE-BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF PANCREATIN VS. PLACEBO FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY - Pancreatin vs. Placebo in Patients with Pancreatic Exocrine Insufficiency The purpose of this clinical trial is to evaluate the clinical efficacy and safety of a capsule containing enteric-coated porcine pancreatin microfilm tablets in comparison with placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis.
MedDRA version: 7.0;Level: LLT;Classification code 10033622
Trade Name: Panzytrat 25.000
Product Name: Panzytrat 25.000
Product Code: Pancreatin
INN or Proposed INN: Pancreatin
Axcan Pharma S.A.NULLNot RecruitingFemale: yes
Male: yes
20Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00957151
(ClinicalTrials.gov)
April 200411/8/2009Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic PancreatitisEvaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic PancreatitisChronic PancreatitisDrug: CreonHospital AvicenneSolvay PharmaceuticalsCompleted18 Years65 YearsBoth12Phase 4France
92NCT00319358
(ClinicalTrials.gov)
October 200326/4/2006Role of Antioxidants Supplementation in Chronic PancreatitisEffect of Antioxidant Supplementation on Pain, Antioxidant Profile and Oxidative Stress in Patients With Chronic PancreatitisChronic PancreatitisDietary Supplement: Antioxidants;Dietary Supplement: PlaceboAll India Institute of Medical Sciences, New DelhiNULLCompleted12 Years70 YearsBoth127Phase 3India
93NCT00583271
(ClinicalTrials.gov)
June 200220/12/2007A Prospective Study of EUS Guided Celiac BlockA Prospective Study of Endoscopic Ultrasound-guided Celiac (CB) EffectivenessChronic Pancreatitis;Pancreatic CancerDrug: triamcinolone;Drug: 98% dehydrated alcoholIndiana UniversityNULLCompleted18 YearsN/ABoth127N/AUnited States