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NCT02009163 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 418
- Enrollment target
NCT02009163 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 418 participants.
The verdict
NCT02009163, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 418 participants
- Enrollment target
Study Summary
To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impression - Severity (CGI-S) scores for patients who responded to SPD489 by the end of the Open-label Treatment Phase.
Interventions
- OTHER Placebo
- DRUG Lisdexamfetamine dimesylate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2014-01-27 |
| Est. Completion | 2015-04-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02009163
The ClinicalTrials.gov registry entry for NCT02009163 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 418 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02009163 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02009163 about?
NCT02009163 is a clinical study titled "Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder". To evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary and Clinical Global Impressio...
What is the current status of trial NCT02009163?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2014-01-27. Estimated completion is 2015-04-08.
What interventions are being tested in trial NCT02009163?
The interventions under investigation include: Placebo (OTHER), Lisdexamfetamine dimesylate (DRUG).
Who is sponsoring clinical trial NCT02009163?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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