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

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Analgesics, Opioid; Tegaserod

Criteria

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