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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: Clinical Trial Phase 3 study, sponsored by GlaxoSmithKline.
NCT01318993 is a Phase 3 study that was terminated before completion, run by GlaxoSmithKline. The registered enrollment target is 399 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death; was life threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; was a congenital anomaly/birth defect. The Safety popula
Interventions
- DRUG GSK1605786A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 399 participants |
| Start Date | 2011-04-01 |
| Est. Completion | 2013-10-29 |
| Phase | Phase 3 |
Why NCT01318993 stopped before completion
NCT01318993 is an interventional study that assigns participants to a tested intervention. The registered 399 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 (48% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK1605786A is the first listed.
NCT01318993 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01318993's enrollment target sits among peer trials
399 962nd of 2000 higher than 1,038 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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