Clinical trial NCT03523520: Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation
Official title: Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Constipation Drug Induced
Keywords: constipation
opioid
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of three groups i. Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection ii. Methylnaltrexone 12mg subcutaneous injection + placebo sugar tablets iii. Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
Primary purpose: TREATMENT

Brief 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.

Detailed description: Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.

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

Primary outcomes:
measure: Occurrence of Bowl Movement
timeFrame: 24 hours
Secondary outcomes:
measure: Time to Bowl Movement Within 24 Hours
timeFrame: 24 hours after administration of study drug
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Kara B. Goddard
state: Missouri
Study officials:
affiliation: UNIVERSITY OF MISSOURI HEALTH CARE
name: KARA B GODDARD, PharmD, BCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.