Opioid induced bowel dysfunction
Conditions
Interventions
Product Name: MOA-728 Capsule 10 mg
Pharmaceutical Form: Gastro-resistant capsule*
INN or Proposed INN: methylnaltrexone bromide
CAS Number: 73232-52-7
Current Sponsor code: MOA-728
Other descriptive
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatient men and women who are at least 18 years of age and able to sign an informed consent form. 2. A history of chronic non-malignant pain with a documented history of the non-malignant condition (ie, osteoarthritis, back pain, or neuropathic pain) underlying the chronic pain of at least 2 months duration before the screening visit. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 at the screening visit. 4. Stable pain and medical status for at least 1 month before the screening visit. 5. Taking oral, transdermal, intravenous, or subcutaneous opioids for at least 1 month and receiving a daily dose = 20 mg of morphine equivalents per day for at least 2 weeks before the screening visit and during the single-blind, placebo run-in period with no changes anticipated during the study. 6. 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 methylnaltrexone. 2. Women who are pregnant, are breastfeeding, or plan to become pregnant during the study. 3. A diagnosis of inflammatory bowel disease, irritable bowel syndrome, impaction, bowel obstruction, adhesions, megacolon, rectal prolapse, fecal incontinence, or other significant gastrointestinal disorder or history of gastrointestinal surgery likely to affect absorption or disposition of an orally administered drug. 4. History of rectal bleeding unexplained by hemorrhoids or fissures. 5. Need for manual disimpaction or pelvic floor support techniques, including manual maneuvers, within 14 days before the screening visit. 6. Clinical evidence of outlet obstruction or impaction on physical examination. 7. Current diagnosis of malignancy other than basal- or squamous- cell skin carcinoma. 8. A history of chronic constipation before the initiation of opioid therapy. 9. A history of alcohol or drug abuse within 1 year before the screening visit. 10. Any unstable hepatic, renal, pulmonary, cardiovascular (including uncontrolled hypertension), ophthalmologic, neurologic, or psychiatric disease, or any other medical condition that might compromise the study or put the subject at greater risk during study participation. 11. A history or presence of orthostatic hypotension. 12. A creatinine value > 2 times the upper limit of normal on screening laboratory tests. 13. An alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2 times the upper limit of normal on screening laboratory tests. 14. Other clinically important abnormalities, as determined by the investigator, on screening physical examination, electrocardiogram (ECG), or laboratory tests. 15. Planned surgery during the study. 16. Known allergy, hypersensitivity, or other contraindication to opioids, opioid derivatives, or opioid antagonists (ie, codeine, naltrexone, or naloxone). 17. Current treatment with partial opioid agonists (eg, buprenorphine) or combination agonists/antagonists. 18. Use of investigational treatments within 14 days of the screening visit. 19. Non-compliance with test article (> 3 consecutive days) or subject diary completion (> 3 days) during the placebo run-in period. 20. Involvement in litigation related to the subject’s underlying medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy, safety, and tolerability of oral MOA-728 given daily in a population of subjects with chronic, non-malignant pain who have opioid-induced bowel dysfunction. ;Secondary Objective: 1) evaluating the dose-response relationship of oral MOA-728 in producing spontaneous bowel movements (SBMs) as a basis for dose selection for subsequent clinical investigations. 2) evaluating potential exposure-response relationships. 3) exploring subject reported outcomes for perceived benefits of treatment with MOA-728.;Primary end point(s): The change from baseline in the number of spontaneous bowel movements (SBMs) per week during the double-blind treatment period. | — |
Countries
Hungary, Netherlands, Sweden, United Kingdom
Outcome results
None listed