Trial Details
Not RecruitingBasic Information
| Clinical ID | c3364 |
|---|---|
| Identifier | EUCTR2005-005363-28-GB |
| Trial Title | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN's PATIENTS WITH FISTULAS |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn's disease. Crohn's disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn's patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. |
| Interventions | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 Pharmaceutical Form: Granules INN or Proposed INN: AST-120 Current Sponsor code: AST-120 Other descriptive name: Kremezin, Spherical Adsorptive Carbon Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use |
Participant Information
| Sponsor | Ocera Therapeutics, Inc. |
|---|---|
| City | - |
| Country/Region | Hungary;Czech Republic;Belgium;Austria;Germany;United Kingdom |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | - |
Study Design
| Study Type | Interventional clinical trial of medicinal product |
|---|---|
| Phase | PHASE3 |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |