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Mu-opioid Receptor Antagonist

Methylnaltrexone oral tablets for Constipation

Phase 4

Waitlist Available

Led By KARA B GODDARD, PharmD, BCPS

Research Sponsored by University of Missouri-Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial is testing whether a mu-opioid receptor antagonist given as a shot works better than a pill to relieve constipation in people who haven't responded to other treatments.

Eligible Conditions

Drug-Induced Constipation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Bowel Movement

Secondary outcome measures

Subcutaneous vs Oral

Trial Design

3Treatment groups

Active Control

Group I: Methylnaltrexone oral tabletsActive Control1 Intervention

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.

Group II: Methylnaltrexone subcutaneous injectionActive Control1 Intervention

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.

Group III: Naloxegol oral tabletsActive Control1 Intervention

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.

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Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

361 Previous Clinical Trials

627,979 Total Patients Enrolled

KARA B GODDARD, PharmD, BCPSPrincipal InvestigatorUNIVERSITY OF MISSOURI HEALTH CARE

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Methylnaltrexone been granted authorization from the FDA for oral tablets?

"The safety of Methylnaltrexone oral tablets was assessed to be a 3, given that its Phase 4 status attests to the drug's approval."

Answered by AI

How many participants are presently enrolled in this experiment?

"Affirmative. Clinicaltrials.gov displays that this clinical trial, which began on December 23rd of 2020, is still recruiting patients. The research team seeks to enroll 60 individuals at a single location."

Answered by AI

Does this research currently accept new participants?

"Yes, the information available on clinicaltrials.gov verifies that this trial is actively seeking patients to participate. The initial post was made on December 23rd 2020 with a recent update occurring March 23rd 2022. Currently, 60 individuals need be recruited from 1 medical centre."

Answered by AI

Recent research and studies

American Journal of Hospice and Palliative Medicine®Journal

Naloxegol

Jones, Rachel, Eric Prommer, and David Backstedt. 2016. “Naloxegol”. American Journal of Hospice and Palliative Medicine®. SAGE Publications. doi:10.1177/1049909115593937.

Journal of Pharmacy PracticeJournal

The Evolving Role of Long-term Pharmacotherapy for Opioid-induced Constipation in Patients Being Treated for Noncancer Pain

Bowers, Brandi L., and Andrew J. Crannage. 2017. “The Evolving Role of Long-term Pharmacotherapy for Opioid-induced Constipation in Patients Being Treated for Noncancer Pain”. Journal of Pharmacy Practice. SAGE Publications. doi:10.1177/0897190017745395.

Journal of Pharmacology and PharmacotherapeuticsJournal

Naloxegol: First Oral Peripherally Acting Mu Opioid Receptor Antagonists for Opioid-induced Constipation

Anantharamu, Tejus, Sushil Sharma, Ajay Kumar Gupta, Navdeep Dahiya, Dick B. Singh Brashier, and Ashok Kumar Sharma. 2015. “Naloxegol: First Oral Peripherally Acting Mu Opioid Receptor Antagonists for Opioid-induced Constipation”. Journal of Pharmacology and Pharmacotherapeutics. SAGE Publications. doi:10.4103/0976-500x.162015.

Journal of Pharmacology and PharmacotherapeuticsJournal