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:
Participant gender:
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.