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NCT00399659 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
A Phase 3 study, sponsored by Novartis.
- Terminated
- Registry status
- Phase 3
- Development phase
- 360
- Enrollment target
NCT00399659 is a Phase 3 study that was terminated before completion, run by Novartis. The registered enrollment target is 360 participants.
The verdict
NCT00399659, a Phase 3 study, was terminated before completion, sponsored by Novartis.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 360 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows: Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind). Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label) Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.
Interventions
- DRUG Tegaserod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2006-11 |
| Est. Completion | 2007-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00399659
The ClinicalTrials.gov registry entry for NCT00399659 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tegaserod is the first listed.
NCT00399659 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00399659 about?
NCT00399659 is a clinical study titled "Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.". This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows: Patients on tegaserod 6 mg twice daily (...
What is the current status of trial NCT00399659?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2006-11. Estimated completion is 2007-04.
What interventions are being tested in trial NCT00399659?
The interventions under investigation include: Tegaserod (DRUG).
Who is sponsoring clinical trial NCT00399659?
This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.
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