drugset / Trial / NCT03523520
Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2020-12-23
- Primary completion
- 2023-03-31
- Completion
- 2023-03-31
Publications
- Background Bowers BL, Crannage AJ. The Evolving Role of Long-Term Pharmacotherapy for Opioid-Induced Constipation in Patients Being Treated for Noncancer Pain. J Pharm Pract. 2019 Oct;32(5):558-567. doi: 10.1177/0897190017745395. Epub 2017 Dec 5.
- Results Jones R, Prommer E, Backstedt D. Naloxegol: A Novel Therapy in the Management of Opioid-Induced Constipation. Am J Hosp Palliat Care. 2016 Nov;33(9):875-880. doi: 10.1177/1049909115593937. Epub 2015 Jul 6.
- Results Anantharamu T, Sharma S, Gupta AK, Dahiya N, Singh Brashier DB, Sharma AK. Naloxegol: First oral peripherally acting mu opioid receptor antagonists for opioid-induced constipation. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):188-92. doi: 10.4103/0976-500X.162015.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylnaltrexone | Other / unclassified | 12 mg | Subcutaneous |
| Comparator | Methylnaltrexone | Other / unclassified | 450 mg | Oral |
| Comparator | Naloxegol | Small molecule | 25 mg | Oral |