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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
60 Investigative Sites
East Hanover, New Jersey, United States
2 Investigative Sites
Hong Kong, China
6 Investigative Sites
Egypt, Egypt
1 Investigative Site
Singapore, Singapore
2 Investigative Sites
Dawan, Taiwan
4 Investigative Sites
Venezuela, Venezuela
To evaluate the long term safety of tegaserod
Change from baseline assessment of OIC symptoms at weeks 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52
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