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 (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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Long term safety of tegaserod
- 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
|Study Start Date:||November 2006|
|Study Completion Date:||April 2007|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
Show 57 Study Locations
|Study Chair:||Novartis Pharmaceuticals Corp.||NPC|