Pentasa Compact 4g, granulate with prolonged release ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 97 | Ulcerative colitis | 4 |
97. Ulcerative colitis
Clinical trials : 2,527 / Drugs : 1,465 - (DrugBank : 259) / 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 | EUCTR2015-002557-35-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 2 | EUCTR2015-002557-35-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 3 | EUCTR2015-002557-35-HU (EUCTR) | 09/02/2016 | 16/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 4 | EUCTR2015-002557-35-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Active, mild to moderate ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia |