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NCT01277666 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 608
- Enrollment target
NCT01277666 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 608 participants.
The verdict
NCT01277666, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 608 participants
- Enrollment target
Study Summary
This is 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 as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed by proportion of subjects achieving response, defined as a decrease in Crohn's Disease Activity Index (CDAI) score of at least 100 points (clinical response). Clinical remission (CDAI score less than 150 points) will be evaluated as a key secondary endpoint. Safety will be assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram (ECG). Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), Short Form-36 version 2 (SF-36v2), EQ-5D and Work Productivity and Activity Impairment-CD (WPAI-CD) and receipt of disability.
Interventions
- DRUG Placebo
- DRUG GSK1605786A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 608 participants |
| Start Date | 2010-12-20 |
| Est. Completion | 2013-07-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01277666
The ClinicalTrials.gov registry entry for NCT01277666 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 608 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.
NCT01277666 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01277666 about?
NCT01277666 is a clinical study titled "A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn's Disease". This is 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 as compared to placebo over 12 weeks in adult subjects with moderately-to-severely active Crohn's disease. Efficacy will be assessed...
What is the current status of trial NCT01277666?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 608 participants. The study started on 2010-12-20. Estimated completion is 2013-07-11.
What interventions are being tested in trial NCT01277666?
The interventions under investigation include: Placebo (DRUG), GSK1605786A (DRUG).
Who is sponsoring clinical trial NCT01277666?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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