A Phase 3 interventional study of Tegaserod in Opioid-induced Constipation, sponsored by Novartis. Terminated at 57 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-01.
Sponsored by Novartis · Phase 3, Interventional, and Treatment
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.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 360 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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
This study is terminated, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Novartis