TerminatedPhase 3

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

Stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007

United States360 participantsStarted 2006-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Long term safety of tegaserod

Trial details

NCT IDNCT00399659

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04

View on ClinicalTrials.gov More Opioid-induced Constipation trials