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NCT01318993 · ClinicalTrials.gov registry record · Phase 3
Open-Label Extension Study of GSK1605786A
A Phase 3 study, sponsored by GlaxoSmithKline.
- Terminated
- Registry status
- Phase 3
- Development phase
- 399
- Enrollment target
NCT01318993 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 399 participants.
The verdict
NCT01318993, a Phase 3 study, was terminated before completion, sponsored by GlaxoSmithKline.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 399 participants
- Enrollment target
Study Summary
An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.
Interventions
- DRUG GSK1605786A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2013-10-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01318993
The ClinicalTrials.gov registry entry for NCT01318993 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 399 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.
NCT01318993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01318993 about?
NCT01318993 is a clinical study titled "Open-Label Extension Study of GSK1605786A". An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK16057...
What is the current status of trial NCT01318993?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2011-04-01. Estimated completion is 2013-10-29.
What interventions are being tested in trial NCT01318993?
The interventions under investigation include: GSK1605786A (DRUG).
Who is sponsoring clinical trial NCT01318993?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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