Phase 4
Completed N=149
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
Opioid-Induced Constipation
Source: ClinicalTrials.gov NCT00672139 ↗
Enrolled (actual)
149
Serious AEs
39.6%
Results posted
Mar 2018
Primary outcomePrimary: Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. — 1.7; 2.4; 2.6; 3.4 Number of laxations
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. |
1.7; 2.4; 2.6; 3.4 | — |
Eligibility Criteria
Inclusion Criteria
- Has completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
- Is receiving opioids on a regular schedule, not just as needed to control pain.
- Likely to continue to need treatment of OIC for the duration of participation in the study.
Exclusion Criteria
- Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
- Currently using an opioid antagonist or partial antagonist.
- Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
Data sourced from ClinicalTrials.gov (NCT00672139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.