TOP1288 ( DrugBank: TOP-1288 )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
97潰瘍性大腸炎10

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Status
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1NCT03071081
(ClinicalTrials.gov)
February 8, 201720/2/2017Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy SubjectsA Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy VolunteersUlcerative ColitisDrug: TOP1288;Drug: Placebo to TOP1288Topivert Pharma LtdNULLCompleted18 Years55 YearsMale37Phase 1United Kingdom
2NCT02888379
(ClinicalTrials.gov)
September 201630/8/2016Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative ColitisA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients With Moderate to Severe Disease ActivityUlcerative ColitisDrug: TOP1288;Drug: Placebo (for TOP1288)Topivert Pharma LtdNULLCompleted18 Years75 YearsAll77Phase 2Bulgaria;Czechia;Hungary;Latvia;Lithuania;Poland;Ukraine;United Kingdom;Czech Republic
3EUCTR2016-000390-20-BG
(EUCTR)
29/08/201618/07/2016A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
4EUCTR2016-000390-20-CZ
(EUCTR)
18/07/201618/07/2016A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate to Severe DiseaseActivity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
5EUCTR2016-000390-20-LT
(EUCTR)
15/07/201605/07/2016A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
6EUCTR2016-000390-20-HU
(EUCTR)
05/07/201614/06/2016A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Czech Republic;Hungary;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
7EUCTR2016-000390-20-PL
(EUCTR)
28/06/201616/06/2016English A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
8EUCTR2016-000390-20-LV
(EUCTR)
17/06/201614/06/2016A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study toEvaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg RectalSolution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patientswith Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity
MedDRA version: 19.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
9EUCTR2016-000390-20-GB
(EUCTR)
10/06/201606/06/2016 A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease ActivityA Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity
MedDRA version: 19.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: TOP1288 Rectal solution
INN or Proposed INN: Not Applied for
Other descriptive name: TOP1288 rectal solution
TOPIVERT Pharma LimitedNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom
10NCT02463045
(ClinicalTrials.gov)
May 201526/5/2015Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis SubjectsA Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative ColitisUlcerative ColitisDrug: TOP1288Topivert Pharma LtdNULLCompleted18 Years55 YearsAll67Phase 1United Kingdom