Opioid-induced Constipation
Conditions
Keywords
Opioid, constipation, tegaserod
Brief summary
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.
Interventions
DRUGTegaserod
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patient has completed the 12 week double blind treatment of study CHTF919N2201
Exclusion criteria
* Planned discontinuation of opioids during the study. * Development of any of the medical conditions listed as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long term safety of tegaserod | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed