Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
- Conditions
- Opioid-induced Constipation
- Registration Number
- NCT00399659
- Lead Sponsor
- Novartis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 360
- Patient has completed the 12 week double blind treatment of study CHTF919N2201
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Long term safety of tegaserod
- Secondary Outcome Measures
Name Time Method Change from baseline assessment of OIC symptoms, at week 24 and 52 Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52 Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
Trial Locations
- Locations (1)
Investigative Site
🇺🇸Seattle, Washington, United States