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Dose Finding Study of BIRB 796 BS in Patients With Moderate to Severe Crohn's Disease

NCT02209792 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2014-08-06

No results posted yet for this study

Summary

The primary objective of this extension study was to obtain long-term safety data for BIRB 796 BS in patients with moderate to severe Crohn's disease after 26 weeks of treatment. Secondary objectives were the evaluation of efficacy of BIRB 796 BS to induce clinical remission and response over 26 weeks of treatment.

Conditions

  • Crohn Disease

Interventions

DRUG

Placebo

DRUG

BIBR 796 BS, 5 mg

DRUG

BIBR 796 BS, 20 mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2004-01-31

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02209792 on ClinicalTrials.gov