Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
Status:
Terminated
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
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.