Lactose ( DrugBank: Lactose )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症2
6パーキンソン病3
13多発性硬化症/視神経脊髄炎1
97潰瘍性大腸炎1
228閉塞性細気管支炎1
310先天異常症候群1

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT02463825
(ClinicalTrials.gov)
April 201521/4/2015A Registry-Based Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to ALSA Registry-Based Randomized-Controlled, Double-Blinded Clinical Trial of Pimozide in Patients With Neuromuscular Junction Transmission Dysfunction Due to Amyotrophic Lateral SclerosisAmyotrophic Lateral Sclerosis (ALS)Drug: Pimozide 2 mg per day;Drug: Pimozide 4 mg per day;Drug: Placebo (Lactose tablet)University of CalgaryHotchkiss Brain Institute, University of CalgaryActive, not recruiting18 YearsN/ABoth25Phase 2Canada
2JPRN-UMIN000008527
2009/01/0125/07/2012Study of efficacy and safety of NDDPX08 in ALS patientsStudy of efficacy and safety of NDDPX08 in ALS patients - NDDPX08-ALS clinical research Amyotrophic Lateral SclerosisFor patients who begin to receive Rilutek treatment at the start or 4 weeks before the start of the observation period, the 12-week treatment with Rilutek alone (100 mg/day) during the observation period is followed by combined treatment (Rilutek + NDDPX08). The NDDPX08 dose level begins at 1.25 mg/day and is increased in steps to 15 mg/day during the 12-week treatment period according to the dose escalation schedule given on the next page (Fig. 1). If any serious adverse reaction arises following a dose increase to 10 mg/day and it is judged to be difficult to maintain this dose level, the dose level of 7.5 mg/day is regarded as the maintenance dose level. If alleviation of symptoms is noted during dose escalation steps, the dose level producing alleviation of symptoms is used as the maintenance dose level.
The total NDDPX08 treatment period is 58-90 weeks (including the 4 weeks during which the dose level is reduced in steps). Follow-up of adverse events is continued until 1 month after the end of NDDPX08 treatment.
Placebo (lactose) is administered to 10 of the 50 subjects planned to be enrolled in the study.
FeGALSNULLComplete: follow-up complete20years-old75years-oldMale and Female50Not selectedJapan

6. パーキンソン病


臨床試験数 : 2,307 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1JPRN-UMIN000022529
2016/06/0101/06/2016Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's diseaseEffects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease - Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease Parkinson's disease8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg)
Washout 6days

8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap
8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap
Washout 6days

8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg)
Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up complete20years-old85years-oldMale and Female8Phase 3Japan
2JPRN-UMIN000020527
2016/02/0101/02/2016Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's diseaseMulti-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's disease Parkinson's diseaseInosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years
Lactose as a placebo for 2 years
Ehime University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female100Phase 2Japan
3JPRN-UMIN000007896
2012/05/0107/05/2012Levodopa challenge test for Parkinson's disease and other parkinsonian syndromesLevodopa challenge test for Parkinson's disease and other parkinsonian syndromes - Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes Parkinson's disease and other parkinsonian syndromesThe patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
Kansai Medical UniversityNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
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size
PhaseCountries
1EUCTR2012-004847-61-GB
(EUCTR)
16/01/201318/12/2012INSPIRE: Raltegravir (Isentress) Pilot Study in Relapsing MSA phase II baseline versus treatment study to determine the efficacy of raltegravir (ISENTRESS) in preventing progression of relapsing remitting multiple sclerosis as determined by gadolinium-enhanced MRI - INSPIRE (Isentress Pilot Study in Relapsing MS) Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: ISENTRESS
Product Name: raltegravir
INN or Proposed INN: lactose monohydrate
Queen Mary University of LondonNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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size
PhaseCountries
1NCT00403923
(ClinicalTrials.gov)
April 200724/11/2006Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative ColitisA Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative ColitisLactose Intolerance;Ulcerative ColitisDietary Supplement: Lactose in waterUniversity Hospitals, LeicesterNULLCompleted18 YearsN/ABoth48United Kingdom

228. 閉塞性細気管支炎


臨床試験数 : 97 薬物数 : 118 - (DrugBank : 32) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 156
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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size
PhaseCountries
1NCT00624754
(ClinicalTrials.gov)
March 200815/2/2008Prospective Evaluation of the Efficacy of Budesonide/Formoterol in Bronchiolitis Obliterans in AHSCTrecipientsProspective Evaluation of the Efficacy of Budesonide/Formoterol (Symbicort®) in Bronchiolitis Obliterans in Allogeneic Haematopoietic Stem Cell Transplantation (AHSCT) RecipientsObstructive Airway DiseaseDrug: Formoterol/Budesonide;Drug: lactoseAssistance Publique - Hôpitaux de ParisAstraZenecaCompleted16 YearsN/ABoth32Phase 2France

310. 先天異常症候群


臨床試験数 : 11 薬物数 : 20 - (DrugBank : 10) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 7
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1NCT01434745
(ClinicalTrials.gov)
September 20117/9/2011SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol SupplementationSmith-Lemli Opitz Syndrome: A Clinical Investigation of the Effect of Simvastatin in Patients Receiving Cholesterol SupplementationSmith-Lemli-Opitz SyndromeDrug: Simvastatin;Dietary Supplement: LactoseOregon Health and Science UniversityNational Heart, Lung, and Blood Institute (NHLBI)Terminated1 Year89 YearsAll1N/AUnited States