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Naloxegol 25 MG for Constipation

Phase 2 & 3

Waitlist Available

Led By Scott McCardle, MD

Research Sponsored by TriHealth Inc.

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 post-operative day 5

Awards & highlights

Study Summary

This trial is testing whether adding naloxegol to a cardiac surgery pre-operative regimen is effective.

Eligible Conditions

Constipation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative day 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 5 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 substantial bowel movement

Secondary outcome measures

Rescue medications

Other outcome measures

Length of stay

Side effects data

From 2022 Phase 4 trial • 136 Patients • NCT03235739

Troponin elevation and ST elevation

100%

80%

60%

40%

20%

Study treatment Arm

Treatment-Naloxegol

Placebo Arm

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NaloxegolExperimental Treatment1 Intervention

naloxegol 25 mg pill

Group II: PlaceboPlacebo Group1 Intervention

placebo pill

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naloxegol 25 MG

2017

Completed Phase 4

~140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TriHealth Inc.Lead Sponsor

97 Previous Clinical Trials

53,320 Total Patients Enrolled

2 Trials studying Constipation

169 Patients Enrolled for Constipation

Scott McCardle, MDPrincipal InvestigatorBethesda North TriHealth Hospital

Frequently Asked Questions

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

Can patients still join this trial?

"The clinicaltrials.gov website indicates that this research is actively looking for volunteers. The listing was originally created on November 6th, 2017 and the most recent update was on April 29th, 2022."

Answered by AI

What is the total number of people signed up for this clinical trial?

"Yes, as of 4/29/2022, this trial is still recruiting patients which it began searching for on 11/6/2017. So far, 1 location has been utilized to find the 280 patients needed for the study."

Answered by AI

Recent research and studies

Pain and TherapyJournal

Oxycodone/naloxone: Role in Chronic Pain Management, Opioid-induced Constipation, and Abuse Deterrence

DePriest, Anne Z., and Katie Miller. 2014. “Oxycodone/naloxone: Role in Chronic Pain Management, Opioid-induced Constipation, and Abuse Deterrence”. Pain and Therapy. Springer Science and Business Media LLC. doi:10.1007/s40122-014-0026-2.

New England Journal of MedicineJournal

Naloxegol for Opioid-induced Constipation in Patients with Noncancer Pain

Chey, William D., Lynn Webster, Mark Sostek, Jaakko Lappalainen, Peter N. Barker, and Jan Tack. 2014. “Naloxegol for Opioid-induced Constipation in Patients with Noncancer Pain”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1310246.

Therapeutic Advances in GastroenterologyJournal

Chronic Opioid Induced Constipation in Patients with Nonmalignant Pain: Challenges and Opportunities

Nelson, Alfred D., and Michael Camilleri. 2015. “Chronic Opioid Induced Constipation in Patients with Nonmalignant Pain: Challenges and Opportunities”. Therapeutic Advances in Gastroenterology. SAGE Publications. doi:10.1177/1756283x15578608.

New England Journal of MedicineJournal