Budenofalk® suppositories (BUS) ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 97 | Ulcerative colitis | 3 |
97. Ulcerative colitis
Clinical trials : 2,630 / Drugs : 1,459 - (DrugBank : 265) / Drug target genes : 144 - Drug target pathways : 202
| 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 | EUCTR2019-003334-16-LV (EUCTR) | 29/04/2021 | 14/01/2021 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Bulgaria;Russian Federation;Germany;Latvia | ||
| 2 | EUCTR2019-003334-16-BG (EUCTR) | 11/03/2021 | 02/12/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Germany;Latvia | ||
| 3 | EUCTR2019-003334-16-DE (EUCTR) | 26/06/2020 | 05/05/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany |