Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo
NCT00739986 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152
Last updated 2023-11-09
Summary
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).
Conditions
Interventions
- DRUG
-
Semapimod
semapimod 60 mg IV x 1 day, placebo x 2 days
- DRUG
-
Semapimod
Semapimod 60 mg IV x 3 days
- DRUG
-
placebo IV x 3 days
Sponsors & Collaborators
-
Ferring Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Daan Hommes, MD · Academic Medical Center, Netherlands
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-10-31
- Primary Completion
- 2004-06-30
- Completion
- 2004-08-31
Countries
- United States
- Belgium
- Germany
- Israel
- Netherlands
Study Locations
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