Opioid-induced constipation in subjects with non-malignant pain Tratamiento del estreñimiento inducido por opiáceos en sujetos con dolor de origen no maligno MedDRA version: 9.1 Level: LLT Classification code 10010774 Term: Constipation
Conditions
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects aged 18 years or older. 2. Subjects weighing ? 40 kg. 3. A history of pain with documentation of a nonmalignant condition underlying the pain of at least 2 month?s duration before the screening visit. 4. Taking oral, transdermal, intravenous, or SC opioids for at least 1 month and receiving a daily dose ? 50 mg of oral morphine equivalents per day for at least 2 weeks before the screening visit with no anticipated changes during the study. 5. A history of constipation due to opioid use for at least 1 month before the screening visit. Constipation is defined as =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with SC methylnaltrexone. 2. Pregnant or breastfeeding women. 3. A diagnosis of bowel obstruction, fecal incontinence, rectal prolapse, acute diverticulitis, or other significant GI disorders. 4. Any history of any inflammatory bowel disease or toxic megacolon or a history of irritable bowel syndrome within 6 months before the screening visit. 5. A recent history of rectal bleeding unexplained by hemorrhoids or fissures. 6. Need for manual disimpaction or pelvic floor support techniques, including manual maneuvers, within 14 days before the screening visit. 7. Clinical evidence of outlet obstruction or impaction. If suspected, a rectal examination must be performed to rule out obstruction or impaction. 8. A history of malignancy, other than basal- or squamous-cell skin carcinoma, within 5 years before the screening visit. 9. A history of laxative use due to chronic constipation before the initiation of opioid therapy. 10. A history of alcohol or drug abuse within 1 year before the screening visit. 11. Any major illness/condition or unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, psychiatric, or any other medical condition that, in the investigator?s 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. 12. A history or presence of symptomatic orthostatic hypotension. 13. Other clinically important abnormalities on screening physical examination findings, laboratory test results, or electrocardiogram (ECG) findings. 14. A calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate [GFR]) < 30 mL/min. 15. Planned surgery during the study. 16. Known or suspected allergy to opioids, opioid derivatives, or opioid antagonists (eg, codeine, naltrexone, or naloxone) or other compounds related to these classes of medications. 17. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists. 18. Urine drug screen negative for the presence of opioids. 19. Urine drug screen positive for a substance of abuse that is not explained by a prescribed medication reported by the subject. 20. Patients who received opioid maintenance therapy (eg, methadone, buprenorphine) for the treatment of addiction. 21. Involvement in litigation related to the subject?s underlying medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with nonmalignant pain who have opioid-induced constipation.;Secondary Objective: Secondary: To explore subject-reported outcomes for benefits of treatment with MOA-728.;Primary end point(s): Two coprimary efficacy endpoints are: 1. the proportion of subjects having a RFBM within 4 hours of the first dose administration, and 2. the percentage of injections resulting in any RFBM within 4 hours during the double-blind period. | — |
Countries
Spain
Outcome results
None listed