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NCT00489255 · ClinicalTrials.gov registry record · Phase 4
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
A Phase 4 study, sponsored by Ipsen.
- Completed
- Registry status
- Phase 4
- Development phase
- 117
- Enrollment target
NCT00489255: Completed Phase 4 study, sponsored by Ipsen.
NCT00489255 is a Phase 4 study that has completed, run by Ipsen. The registered enrollment target is 117 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00489255, a Phase 4 study, has completed, sponsored by Ipsen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 117 participants
- Enrollment target
Study Summary
The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
Interventions
- DRUG Placebo
- DRUG Tigan®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 4 |
What the finished NCT00489255 record still lists
NCT00489255 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00489255 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00489255 about?
NCT00489255 is a clinical study titled "Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment". The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To...
What is the current status of trial NCT00489255?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 117 participants. The study started on 2007-05. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00489255?
The interventions under investigation include: Placebo (DRUG), Tigan® (DRUG).
Who is sponsoring clinical trial NCT00489255?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00489255's enrollment target sits among peer trials
117 714th of 2000 higher than 1,287 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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