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Constipation study for back surgery patients withdrawn before starting

NCT ID NCT04930237

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the study was withdrawn before enrolling anyone, so no results are available.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)

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Started

Jul 2021

Finished

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

18 years and older

Sex

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

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

  • Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

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