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Methylnaltrexone vs Naloxegol in the Treatment of Opioid-Induced Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523520
Recruitment Status : Not yet recruiting
First Posted : May 14, 2018
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kara B. Goddard, PharmD, BCPS, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Constipation Drug Induced Drug: Methylnaltrexone Bromide 150 mg Oral Tablet Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 Drug: Naloxegol 25 MG Oral Tablet Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Each participant will be receiving one injection and tablets which have been randomly assigned.
Primary Purpose: Treatment
Official Title: Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: Methylnaltrexone oral tablets

Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection

Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.

Drug: Methylnaltrexone Bromide 150 mg Oral Tablet
Methylnaltrexone Bromide 150 mg Oral Tablet
Other Name: Relistor

Active Comparator: Methylnaltrexone subcutaneous injection

Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet

Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.

Drug: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1
Methylnaltrexone Bromide 12 MG Subcutaneous Solution
Other Name: Relistor

Active Comparator: Naloxegol oral tablets

Naloxegol oral tablets (total 25 mg) + subcutaneous water injection

Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.

Drug: Naloxegol 25 MG Oral Tablet
Naloxegol 25 MG Oral Tablet
Other Name: Movantik




Primary Outcome Measures :
  1. Time to Bowel Movement [ Time Frame: 24 hours ]
    The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.


Secondary Outcome Measures :
  1. Subcutaneous vs Oral [ Time Frame: 24 hours ]
    The secondary outcome of this study is the time to effectiveness of subcutaneous versus oral therapy.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523520


Contacts
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Contact: Kara B Goddard, PharmD, BCPS 573-884-1605 goddardk@health.missouri.edu
Contact: Julie AW Stilley, PhD 573-884-4400 stilleyj@health.missouri.edu

Sponsors and Collaborators
University of Missouri-Columbia
Publications of Results:
Other Publications:
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Responsible Party: Kara B. Goddard, PharmD, BCPS, Clinical Pharmacy Specialist, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03523520    
Other Study ID Numbers: 2011409 HS
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kara B. Goddard, PharmD, BCPS, University of Missouri-Columbia:
constipation
opioid
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Naltrexone
Bromides
Methylnaltrexone
Naloxegol
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents