Columbia, Missouri 65212

  • Constipation Drug Induced

Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT03523520


Primary Contact:

Principal Investigator
KARA B GODDARD, PharmD, BCPS
UNIVERSITY OF MISSOURI HEALTH CARE

Kara B Goddard, PharmD, BCPS
Phone: 573-884-1605
Email: goddardk@health.missouri.edu


Backup Contact:

Email: stilleyj@health.missouri.edu
Julie AW Stilley, PhD
Phone: 573-884-4400


Location Contact:

Columbia, Missouri 65212
United States

KARA B GODDARD, PharmD, BCPS
Phone: 573-771-7819
Email: GODDARDK@HEALTH.MISSOURI.EDU

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 03, 2021

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