DDrare: Database of Drug Development for Rare Diseases

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.

Drug = 98% dehydrated alcohol; A04AD10; ACETYLCYSTEINE; ANTOX; ANTOX (vers) 1.2; ANTOX (vers.)1.2; ASCORBIC ACID; Acetate; Acetyl-L-carnitine; Acetyl-L-carnitine 1000mg 2X per day for 3 months; Acetylcysteine; Alanine; Alcohol; Alpha 1-Antitrypsin; Alpha 1-antitrypsin; Amino acids; Amlodipine; Amlodipine (drug); Analgesics; Antioxidant plus Pregabalin; Antioxidants; Antox version 1.2; Ascorbic acid; Autologous mesenchymal stromal cell; Behavioral: smoking and alcohol assumption; Benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala); Bupivacaine; Bupivicaine alone; CREON; Calcium; Calcium, Dietary; Carbon; Carbon monoxide; Carnitine; Cholecalciferol; Creon; Creon 10000; Creon 25000; Creon36™; DRONABINOL; Device: Mayo Interactive Breath Hold Monitor; Diagnostic Test: Hemoglobin A1c; Diagnostic Test: Mixed Meal Tolerance Test; Diagnostic Test: Other exploratory blood biomarkers; Diagnostic Test: genetic sequencing; Diazepam; Dronabinol; ERCP with Bupivacaine infusion; EUR-1008 (APT-1008) High Dose; EUR-1008 (APT-1008) Low Dose; EUR-1066-A; EUR-1066-B; EUS procedure with drug injection; Ensure Surgical; Esomeprazole; Etanercept; FLUIMUCIL*20CPR EFF 600MG; Fluimucil; Gabapentin; Gabapentin prescriptions; Gold; Helopanflat Mono®; Hemoglobin; Human Secretin; Human secretin; Hydroxychloroquine; Indomethacin; Intra Plexus Triamcinolone and Bupivicaine Injection; Kreon 25000; L-Carnitine; LANREOTIDE ACETATE; LIPASE; Lannacher; Lanreotide; Liprotamase; Lyrica; Lyrica®; MAGNESIUM ASPARTATE HYDROCHLORIDE; METHIONINE; MONITOR; MS1819; MS1819-SD; Magnesiocard 2.5mmol; Magnesium; Magnesium aspartate; Methionine; Mezym F; Midazolam; Multienzymes (lipase, protease etc.); NI-03; Namisol; Nexium (esomeprazole magnesium); OXYCODONE; OXYCODONE HYDROCHLORIDE; Omeprazole; Other: Carbon monoxide-bubbled mediums; Other: EUS procedure; Other: Laboratory Biomarker Analysis; Other: Low-intensity exercise therapy; Other: No enzyme therapy; Other: Nutrition counseling; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Oxycodone; Oxycodone Depot ”Sandoz”, depot tablets; Oxycodonhydrochlorid ”Lannacher”, depot tablets; Oxynorm; PFD; PL 00512/0150; Pancreatic enzymes; Pancreatin; Pancrelipase; Pancrelipase Delayed Release Capsule; Pancrelipase delayed release capsule; Pancrelipase/Pancreas Powder; Panzytrat; Panzytrat 25.000; Panzytrat 25.000 FIP-E units of Lipase; Pentoxifylline; Perflubutane; Pioglitazone; Pregabalin; Procedure: Celiac Block with triamcinolone and bupivicaine; Procedure: No Celiac Block; Procedure: endoscopic drainage of the main pancreatic duct; Procedure: extracorporeal shock wave lithotripsy; Prolastin; Prolastin-C; Proton pump inhibitor (PPI); REGN475/SAR164877; RG1068 (Synthetic Human Secretin); RVG 13760; Radiation: UV-filtered light.; Radiation: UVB; Recombinant Microbial Lipase SLV339; Recombinant microbial lipase; Reparixin; S-Ketamin; S-ketamin; SA; SA-001; SELENIUM; SLV339; Secretin; Selenium; Simvastatin; Somatuline; Somatuline Autogel 90 mg; Soy bread; Synthetic human secretin; TOCOPHEROL; Tanezumab; Tetrahydro-6,6,9-tri methyl-3-penthyl-6 H-dibenzo[ b,d ]pyran-1-ol; Tetrahydrocannabinol; Thalidomide; Tocopherol; Triamcinolone; Tyr; VIOKASE 16; Viokase 16; Viokase 16 (pancrelipase) + Nexium; Viokase® 16; Vitamin D; Vitamin D 100ug; Vitamin D 10ug; Yarrowia lipolytica lipase; ZENTASE; Zenpep

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2005-000562-38-DE (EUCTR)	20/04/2010	29/09/2005	RANDOMISED, 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	RANDOMISED, 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 AG	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Germany
2	NCT00705978 (ClinicalTrials.gov)	June 2008	26/6/2008	Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis	A 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 Extension	Pancreatic Insufficiency	Drug: Pancreatin;Drug: Placebo	Abbott Products	Quintiles, Datamap	Completed	18 Years	N/A	Both	62	Phase 3	India
3	EUCTR2005-000736-24-DE (EUCTR)	14/07/2005	13/05/2005	RANDOMISED, 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	RANDOMISED, 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 AG	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Germany
4	EUCTR2004-002468-89-DE (EUCTR)	28/10/2004	23/09/2004	A 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	A 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.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2005-000562-38-DE
(EUCTR)

20/04/2010

29/09/2005

RANDOMISED, 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 AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany

NCT00705978
(ClinicalTrials.gov)

June 2008

26/6/2008

Creon 40,000 for Treatment of PEI (Pancreatic Exocrine Insufficiency) Due to Chronic Pancreatitis

A 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 Extension

Pancreatic Insufficiency

Drug: Pancreatin;Drug: Placebo

Abbott Products

Quintiles, Datamap

Completed

18 Years

N/A

Both

Phase 3

India

EUCTR2005-000736-24-DE
(EUCTR)

14/07/2005

13/05/2005

RANDOMISED, 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 AG

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany

EUCTR2004-002468-89-DE
(EUCTR)

28/10/2004

23/09/2004

A 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.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

Germany