Clinical trial · Interventional
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-induced Constipation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tegaserod | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Long term safety of tegaserod
Secondary outcomes (3)
- measure
- Change from baseline assessment of OIC symptoms, at week 24 and 52
- measure
- Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
- measure
- Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has completed the 12 week double blind treatment of study CHTF919N2201 Exclusion Criteria: * Planned discontinuation of opioids during the study. * Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available