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

Novartis

Status and phase

Terminated

Phase 3

Conditions

Opioid-induced Constipation

Treatments

Drug: Tegaserod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00399659

CHTF919N2201E1

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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