Constipation study for back surgery patients withdrawn before starting
NCT ID NCT04930237
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study was designed to see if the drug RELISTOR could help relieve constipation caused by opioid painkillers in people who had spinal fusion surgery. It planned to compare RELISTOR to standard laxatives in 40 patients. However, the study was withdrawn before enrolling anyone, so no results are available.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Relistor (methylnaltrexone)
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Study facts
What this study's own registry entry says, in plain language.
- Started
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Jul 2021
- Finished
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Apr 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients diagnosed with acute OIC in postoperative spinal surgery patients, specifically those undergoing 1-2 level anterior lumbar interbody fusion (ALIF) at Methodist Dallas Medical Center (MDMC)
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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-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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
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