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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: Clinical Trial Phase 3 study, sponsored by Novartis.
NCT00399659 is a Phase 3 study that was terminated before completion, run by Novartis. The registered enrollment target is 360 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00399659 stopped before completion
NCT00399659 is an interventional study that assigns participants to a tested intervention. The registered 360 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 (53% lower).
The record links to 0 conditions, and to 1 intervention - of which Tegaserod is the first listed.
NCT00399659 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00399659's enrollment target sits among peer trials
360 1008th of 2000 higher than 980 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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