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NCT00256854 · ClinicalTrials.gov registry record · Phase 3
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT00256854: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00256854 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256854, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Primary Outcome
AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. In each of the 6 cohorts, there were 2 conversions, one of which was IR to CR-RLS and the other one IR to IR. Two populations were defined: the first conversion population and the second conversion population. The first conversion p
Interventions
- DRUG Ropinirole IR 1 mg
- DRUG Ropinirole IR 2 mg
- DRUG Ropinirole IR 1 mg Placebo
- DRUG Ropinirole IR 2 mg Placebo
- DRUG Ropinirole CR 2 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2005-11-14 |
| Est. Completion | 2006-09-21 |
| Phase | Phase 3 |
What the finished NCT00256854 record still lists
NCT00256854 is an interventional study that assigns participants to a tested intervention. The registered 135 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 (83% lower).
The record links to 0 conditions, and to 5 interventions - of which Ropinirole IR 1 mg is the first listed.
NCT00256854 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00256854 about?
NCT00256854 is a clinical study titled "Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)". This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
What is the current status of trial NCT00256854?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2005-11-14. Estimated completion is 2006-09-21.
What interventions are being tested in trial NCT00256854?
The interventions under investigation include: Ropinirole IR 1 mg (DRUG), Ropinirole IR 2 mg (DRUG), Ropinirole IR 1 mg Placebo (DRUG), Ropinirole IR 2 mg Placebo (DRUG), Ropinirole CR 2 mg (DRUG).
Who is sponsoring clinical trial NCT00256854?
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 NCT00256854's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 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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