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NCT01536418 · ClinicalTrials.gov registry record · Phase 3
An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 255
- Enrollment target
NCT01536418 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 255 participants.
The verdict
NCT01536418, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 255 participants
- Enrollment target
Study Summary
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary objective of the study is to induce clinical response (Crohn's Disease Activity Index \[CDAI\] decrease from baseline of at least 100 points) and/or remission (CDAI score less than 150) with GSK1605786A at Week 12 in subjects with active Crohn's disease to qualify subjects for enrolment into a 52 week maintenance study (CCX114157). Secondary objectives will include assessment of the safety and evaluation of the efficacy in induction of clinical response or remission. Safety will be assessed by recording of adverse events and assessment of changes in clinical laboratory parameters, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire, SF-36, EQ-5D, and Work Productivity and Activity Impairment-Crohn's Disease.
Interventions
- DRUG GSK1605786A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 255 participants |
| Start Date | 2011-11-11 |
| Est. Completion | 2013-10-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01536418
The ClinicalTrials.gov registry entry for NCT01536418 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 255 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 1 intervention - of which GSK1605786A is the first listed.
NCT01536418 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01536418 about?
NCT01536418 is a clinical study titled "An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease". This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease. Subjects will receive one of two doses (500 milligrams once daily, 500 milligrams twice daily) of GSK1605786A for 12 weeks. The primary o...
What is the current status of trial NCT01536418?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 255 participants. The study started on 2011-11-11. Estimated completion is 2013-10-17.
What interventions are being tested in trial NCT01536418?
The interventions under investigation include: GSK1605786A (DRUG).
Who is sponsoring clinical trial NCT01536418?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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