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NCT01316939 · ClinicalTrials.gov registry record · Phase 3
GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 229
- Enrollment target
NCT01316939: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT01316939 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 229 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316939, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 229 participants
- Enrollment target
Study Summary
A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.
Primary Outcome
Clinical remission is defined as a CDAI score \<150 points. In the missing=no effect imputation, participants with missing CDAI scores was considered not to be in clinical remission. Data for percentage of participants in at both Weeks 28 and 52 of the 52-week treatment period have been presented.
Interventions
- DRUG Placebo
- DRUG GSK1605786A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 229 participants |
| Start Date | 2011-05-09 |
| Est. Completion | 2013-10-23 |
| Phase | Phase 3 |
Why NCT01316939 stopped before completion
NCT01316939 is an interventional study that assigns participants to a tested intervention. The registered 229 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01316939 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316939 about?
NCT01316939 is a clinical study titled "GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease". A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Ind...
What is the current status of trial NCT01316939?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 229 participants. The study started on 2011-05-09. Estimated completion is 2013-10-23.
What interventions are being tested in trial NCT01316939?
The interventions under investigation include: Placebo (DRUG), GSK1605786A (DRUG).
Who is sponsoring clinical trial NCT01316939?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316939's enrollment target sits among peer trials
229 1309th of 2000 higher than 692 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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