Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Alvimopan for Opioid-Induced Constipation in Cancer Patients
NCT00331045Phase 2
Key facts
- Status
- Terminated
- Start
- Apr 2006
- Primary completion
- Oct 2006
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- alvimopan
- Conditions
- opioid-induced constipation (OIC)
01
Overview
Phase 2, randomised, double-blind trial of alvimopan in opioid-induced constipation (OIC) (4 arms), sponsored by Merck & Co. Primary endpoint: Change from baseline in average weekly bowel movement frequency with no rescue laxative use at 3 weeks. Started Apr 2006; status: terminated.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo
Alvimopan 0.25 mg/day
Alvimopan 0.25 mg once daily
Alvimopan 0.5 mg/day
Alvimopan 0.25 mg twice daily (total 0.5 mg/day)
Alvimopan 1 mg/day
Alvimopan 0.5 mg twice daily (total 1 mg/day)
03
Who it enrols
Cancer patients taking opioid therapy for intractable pain who are experiencing opioid-induced constipation (less bowel movement frequency compared to pre-opioid treatment).
04
Endpoints
Primary
Change from baseline in average weekly bowel movement frequency with no rescue laxative use
Secondary
Proportion of responders for OBD global improvement
Changes in weekly subjective bowel movement symptoms
Changes in weekly constipation symptoms questionnaire
Beyond the preview
Go deeper on NCT00331045.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00331045.