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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 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 229 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01316939
The ClinicalTrials.gov registry entry for NCT01316939 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 229 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01316939 reports 0 study locations.
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.
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