TOP1288 Rectal solution ( DrugBank: TOP-1288 )


1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis7

97. Ulcerative colitis


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Inclusion_
agemin
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agemax
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PhaseCountries
1EUCTR2016-000390-20-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
2EUCTR2016-000390-20-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
3EUCTR2016-000390-20-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
4EUCTR2016-000390-20-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
5EUCTR2016-000390-20-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
6EUCTR2016-000390-20-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
7EUCTR2016-000390-20-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