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 range
18 Years
Sex
ALL
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-…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.