Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00640146 | Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures | PHASE2 | COMPLETED | 37 | — | — | Oct 19, 2007 | Jan 21, 2009 | Sep 4, 2019 | 1 | United States |
Percentage of participants who had a laxation (that is, bowel movement) within 2 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
Percentage of participants who had a laxation (that is, bowel movement) within 4 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
| Arm | Type | Description |
|---|---|---|
| MNTX | EXPERIMENTAL | Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. |
| Name | Type | Description |
|---|---|---|
| Methylnaltrexone bromide | DRUG | Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. |
| Placebo | DRUG | Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. |
Inclusion Criteria: 1. Male and female participants greater than or equal to (\>=) 18 years of age. 2. Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma). 3. Part...