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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
Investigative Site
Mobile, Alabama, United States
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Phoenix, Arizona, United States
Investigative Site
Tucson, Arizona, United States
Investigative Site
North Little Rock, Arkansas, United States
Investigative Site
Long term safety of tegaserod
Change from baseline assessment of OIC symptoms, at week 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
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Buena Park, California, United States
Investigative Site
Downey, California, United States
Investigative Site
Encinitas, California, United States
Investigative Site
Fountain Valley, California, United States
Investigative Site
La Jolla, California, United States
...and 47 more locations