NCT00414024

Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod 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: 11 (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 in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows: Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1. Patients who enter this study AFTER the core study interim analysis receive the treatment as follows: Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.

Conditions

• Opioid-induced Constipation

Interventions

Type	Name	Description
DRUG	Tegaserod

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-12-20
• Last updated: 2012-04-20

Locations

6 sites across 6 countries: United States, China, Egypt, Singapore, Taiwan, Venezuela