NCT00399659

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Opioid-induced Constipation

Interventions

Type	Name	Description
DRUG	Tegaserod

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2006-11-15
• Last updated: 2012-05-01

Locations

57 sites across 1 country: United States