Phase 4
N=12
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
Constipation Drug Induced
Bottom Line
View on ClinicalTrials.gov: NCT03523520 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Occurrence of Bowl Movement — 2; 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylnaltrexone Bromide 150 mg Oral Tablet (Drug); Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 (Drug); Naloxegol 25 MG Oral Tablet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Bowl Movement |
2; 2; 5 | — |
| SECONDARY Time to Bowl Movement Within 24 Hours |
292.5; 256.5; 270.2 | — |
Summary
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
Eligibility Criteria
Inclusion Criteria
- Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)
- Age≥18y/o
- Not pregnant or lactating (negative urinary pregnancy test)
- No contraindication to Methylnaltrexone or Naloxegol
Exclusion Criteria
- Age<18y/o
- Pregnancy or lactation
- Contraindication to Methylnaltrexone or Naloxegol
- Assigned NPO
- Small bowel obstruction
Data sourced from ClinicalTrials.gov (NCT03523520). 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.