Status and phase
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About
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.
Enrollment
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Inclusion criteria
less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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