RELISTOR's Effects on Opioid-Induced Constipation (NCT04930237) | Clinical Trial Compass
WithdrawnNot Applicable
RELISTOR's Effects on Opioid-Induced Constipation
Stopped: PI request to close study
United States0Started 2021-07-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
Exclusion Criteria:
Experimental Group (post-…