Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-Controlled Double-Blind Study in Cancer Patients-
- Have cancer.
- Taking opioid therapy for continued intractable pain.
- Experiencing less bowel movement frequency compared to that before the opioid
- Must meet the protocol-definition of opioid-induced constipation.
- Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or
induce bowel transit disorder and ileus.
- Subjects, who in the investigator's opinion, have gastrointestinal dysfunction
predominantly due to causes other than the use of opioids.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period
GSK Clinical Trials, MD
Japan: Ministry of Health, Labor and Welfare