A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Nine-weeks Administration of Three Doses of SB-683699 in Subjects With Moderately to Severely Active Crohn's Disease

GlaxoSmithKline1 site in 1 country17 target enrollmentOctober 2004

ConditionsCrohn's Disease

Drugs683699

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Crohn's Disease
Sponsor: GlaxoSmithKline
Enrollment: 17
Locations: 1
Primary Endpoint: Proportion of subjects who are responders at Week 6.
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the effectiveness and safety of the investigational drug 683699 in treating subjects with moderately to severely active CD (Crohn's Disease).

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

July 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Proportion of subjects who are responders at Week 6.

Secondary Outcomes

- Proportion of subjects with response at other timepoints. - Proportion of subjects in remission. - Average rate of response for the CDAI score. - Mean change from baseline in CDAI score Improvement in Quality of Life.