Not Signed In -
Ulcerative Colitis |
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Clinical Trial: Study of Infliximab for the Treatment of Patients with Ulcerative Colitis
This study has been completed.
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Purpose
A research study to evaluate the safety and efficacy of an investigational drug conducted in adults with moderate to severe ulcerative colitis. The aim of the international study is to evaluate the safety and efficacy of infliximab in patients with active ulcerative colitis.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Ulcerative Colitis | Drug: Infliximab | Phase III |
MedlinePlus related topics: Ulcerative Colitis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Official Title: A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients with Active Ulcerative Colitis
Study start: June 2002
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Have had ulcerative colitis for at least 3 months
- Have active disease
- Agree to barrier method birth control
Exclusion Criteria:
- Have severe colitis
- Are pregnant or breast-feeding
- Have used an investigational drug within 30 days prior to screening
- Have received previous treatment with infliximab
- Have a concomitant diagnosis of congestive heart failure
More Information
Record last reviewed: November 2004
Last Updated: November 15, 2004
Record first received: November 12, 2004
ClinicalTrials.gov Identifier: NCT00096655
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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