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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 is a Phase 4 study that has completed, run by Ipsen. The registered enrollment target is 117 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00489255
The ClinicalTrials.gov registry entry for NCT00489255 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 117 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00489255 reports 0 study locations.
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.
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