Opioid-induced constipation in subjects with cancer-related pain Estreñimiento inducido por opiáceos en pacientes con dolor de origen tumoral MedDRA version: 9.1 Level: PT Classification code 10010774 Term: Constipation
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Is a man or woman aged 18 years or older. 2. Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer). 3. Has a life expectancy of ? 6 months. 4. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 5. Is receiving opioids for cancer-related pain, and has been on an around-the-clock regimen, for at least 2 weeks before the first dose of test article. The opioid regimen (oral, transdermal, intravenous, or SC opioids) must be at a daily dose of ? 30 mg of oral morphine equivalents. The dose should not be reduced by ? 50% during this period, although dose increases are permitted. 6. Has a diagnosis of OIC as determined by the investigator. 7. Is willing to follow study-specific laxative use requirements: a. If already taking laxatives or stool softeners, the regimen must have been stable during the 3 days before the screening period, and the subject must be willing to continue the same regimen until the end of the treatment period. b. If not taking laxatives or stool softeners, a regimen must be initiated at the screening visit and the subject must be willing to continue the regimen until the end of the treatment period. c. Rescue laxative use is restricted to sodium phosphate enemas, bisacodyl suppositories, oral bisacodyl, or oral magnesium citrate. d. Rescue laxatives are not to be used within the 48-hour period before the first dose of test article. 8. Had =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Has any nonopioid cause of bowel dysfunction that in the opinion of the investigator is likely to be a major contributor to the constipation. 2. Is administering or receiving opioids only as needed (PRN) or as rescue doses, not on an around-the-clock schedule. 3. Decreased or withheld laxatives during the screening period. 4. Has a history of chronic constipation before initiation of opioid therapy. 5. Has taken or is likely to take prohibited chemotherapy during the screening or treatment periods: a. Has a history of chemotherapy-induced constipation or diarrhea and is scheduled to receive this chemotherapy during the screening or treatment periods. b. Is scheduled to receive chemotherapy during the screening or treatment periods that is known to have or in the opinion of the investigator has a high probability of causing diarrhea or constipation, and in the opinion of the investigator is likely to cause diarrhea or constipation in this patient. c. Has received vinca alkaloids (eg, vincristine, vinblastine, or vinorelbine) within 4 months before screening, or anticipates treatment with vinca alkaloids during the screening or treatment periods. d. Has received irinotecan (CPT-11, camptothecin-11, Camptosar) within 4 weeks before screening, or anticipates treatment with irinotecan during the screening or treatment period. e. Has received cytotoxic agents within 4 weeks before screening, or anticipates such treatment during study participation, unless subject is on a stable regimen that has been reasonably well tolerated in the investigator's judgment (eg, has a toxicity grade of 0, 1, or 2 on the National Cancer Institute [NCI] Common Toxicity Criteria). 6. Has received any prohibited treatments. 7. Has known or suspected radiation enteritis, or is scheduled to receive abdominal or pelvic radiation during screening or treatment periods. 8. Has known or suspected mechanical gastrointestinal obstruction. 9. Has end-stage renal disease receiving dialysis. 10. Has active diverticulitis as determined by the investigator. 11. Has evidence of current fecal impaction determined either by physical examination or previously performed x-ray examination. 12. Has clinical evidence of peritonitis or typhlitis. 13. Has a history of bowel surgery within 1 week before screening visit, or anticipating surgery during the screening, treatment, or follow-up periods of the study. 14. Has a fecal ostomy. 15. Has a known or suspected allergy to methylnaltrexone or other similar compounds (ie, naltrexone or naloxone). 16. Has received any investigational drug or devices within the 30 days before administration of the first dose of test article. 17. Is a pregnant or breastfeeding woman. 18. Has any other clinically important abnormality, that in the investigators judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject?s response 19. Had diarrhea at any time during the screening period. 20. Was noncompliant with opioid or laxative use, or with use of the e-diary during the screening period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the proportion of subjects who have a rescue-free bowel movement within 4 hours after the first dose of study drug.;Main Objective: The objective of this study is to evaluate the efficacy and safety of sub-cutaneous methylnaltrexone in relieving opioid-induced constipation in subjects with cancer-related pain.;Secondary Objective: Not aplicable | — |
Countries
France, Spain
Outcome results
None listed