RELISTOR's Effects on Opioid-Induced Constipation

Withdrawn before enrolling

Conditions studied: OIC

In brief

This will be a prospective case-control study of 40 patients undergoing 1-2 level ALIF procedures at Methodist Dallas Medical Center (MDMC). Patient records will be reviewed to identify details including demographics, comorbidities, procedure details, and the primary and secondary outcome metrics.

Key facts

Study ID

NCT04930237

Run by

Methodist Health System

People needed

0

Starts

2021-07-01

Expected to finish

2022-04-22

Last updated by the study team

2026-03-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Experimental Group (initial screen):
• Age 18 years or older
• Inpatient who will undergo a 1-2 level ALIF procedure with Dr. Richard Meyrat
• Are not pregnant or lactating
• Does not have a history of drug abuse within the past 2 years
• Does not have a gastrointestinal ostomy
• Experimental Group (post-operative OIC screen/rescreen)
• Actively constipated (i.e., no BM in last 48 hours, difficult having a spontaneous BM, or inability to have a spontaneous BM)
• Receiving mu-agonist opioids
• Expected to require daily opioid analgesics for at least 7 days following enrollment
• Have not received or discontinued use of any laxatives, enemas and/or promotility agents within 48 hours of enrollment and the first dose of RELISTOR. Stool softeners are permitted.
• Does not have a known hypersensitivity to methylnaltrexone, naltrexone, or naloxone
• Observational Group (initial screen):
• Age 18 years or older
• Inpatient who will undergo 1-2 level ALIF procedure with Dr. Graham
• Are not pregnant or lactating
• Does not have a history of drug abuse within the past 2 years
• Does not have a gastrointestinal ostomy
• Observational Group (post-operative OIC screen/rescreen):
• Actively constipated (i.e. no BM in last 48 hours, difficulty having a spontaneous BM, or inability to have a spontaneous BM)
• Receiving mu-agonist opioids
• Expected to require daily opioid analgesics for at least 7 days following enrollment

You may not qualify if…

• Experimental Group (post-operative OIC screen/rescreen):
• Exclude patients with:
• Fecal impaction
• Mechanical bowel obstruction
• Constipation not attributed to post-procedural opioid use
• Calculated creatinine clearance less than 50 mL/min
• Corrected QT interval greater than 500 msec. on a 12-lead screening electrocardiogram
• Observational Group (post-operative OIC screen/rescreen):
• Exclude patients with:
• Fecal impaction
• Mechanical bowel obstruction
• Constipation not attributed to post-procedural opioid use

Where it is running

• Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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