OICNCT04930237
RELISTOR's Effects on Opioid-Induced Constipation
An observational study of OIC, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OIC
- What is being tested?
- Relistor Injectable Product, Docusate Calcium and Bisacodyl
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 22 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: RELISTOR's Effects on Opioid-Induced Constipation in Postoperative 1-2 Level Anterior Lumbar Interbody Fusion Patients: A Case-Control Study
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.
Read the detailed description
RELISTOR is a legally marketed device and will be used off-label under the authority of a health care practitioner within a legitimate practitioner-patient relationship with the intent of the "practice of medicine".
The use of RELISTOR in the experimental group of this study meets all of the following conditions:
- is not intended to be reported to the FDA in support of a new indication for use or to support any other significant change in the labeling for the drug;
- it is not intended to support a significant change in the advertising for the product;
- it does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
- it is conducted in compliance with the requirements for IRB review and informed consent [21 CFR parts 56 and 50, respectively];
- it is conducted in compliance with the requirements concerning the promotion and sale of drugs [21 CFR 312.7]; and
- it does not intend to invoke 21 CFR 50.24
Screening and Enrollment:
Patients will undergo two levels of screening: the initial screening and a post-operative OIC screening. The initial screening will involve all 1-2 level ALIF patients in the experimental group and observational group who will be approached to participate in the study before surgery. After eligible patients agree to participate and sign the ICF, all patients will then be asked to complete the PAC-SYM instrument about their constipation symptoms over the past 2 weeks.
Patients in both groups will undergo their 1-2 level ALIF procedure and then will undergo the post-operative OIC screen/rescreen (as needed) daily for acute OIC for a maximum of 3 days (i.e., postoperative days 2 - 4). Patients who are found to have acute OIC will be designated to the experimental and observational treatment regimens accordingly to Study Treatment Regimens.
If a patient does not have acute OIC after they are rescreened on postoperative day 4, are discharged, or do not meet the inclusion criteria, will be placed in the not-constipated or post-operative screen failure group.
- Conditions
- OIC
- Being tested
- Relistor Injectable Product, Docusate Calcium, Bisacodyl, Milk of magnesia, Magnesium citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relistor Injectable ProductDrug
12-mg RELISTOR to be administered as once-daily subcutaneous injections for 4 to 7 days
Docusate CalciumDrug
Standard of care
BisacodylDrug
Standard of Care
Milk of magnesiaDrug
Standard of Care
Magnesium citrateDrug
Standard of Care
SennaDrug
Standard of Care
EnemaDrug
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Patients who receive RELISTOR Receives: Drug: Relistor Injectable Product | |
| Observational Group | Patients that receive standard of care Receives: Drug: Docusate Calcium; Drug: Bisacodyl; Drug: Milk of magnesia; Drug: Magnesium citrate; Drug: Senna; Drug: Enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Movement assessment
Percentage of patients with bowel movement (BM) within four hours of first RELISTOR dose or SOC bowel regimen
Measured: July 2021 - April 2022
Post-treatment Bowel Movement
Time to Bowel Movement after first treatment
Measured: July 2021 - April 2022
Secondary outcomes (3)
Patient Assessment of Constipation Symptoms (PAC-SYM)
to measure patient's self-reported experience of symptoms and symptom severity in constipation pre-operatively and at patients post-operative follow-up
Measured: July 2021 - April 2022
Treatment Satisfaction Questionnaire for Medication
to measure patients' satisfaction with medication
Measured: July 2021 - April 2022
Bowel Function Diary
Daily Assessment Module: to measure constipation symptoms experienced in the past 24 hours during hospitalization
Measured: July 2021 - April 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jul 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Why it stopped: PI request to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OICStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Meyrat, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930237
- Sponsor's protocol ID
- 013.MBSI.2021.D
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2021
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELISTOR's Effects on Opioid-Induced Constipation in Postoperative 1-2 Level Anterior Lumbar Interbody Fusion Patients: A Case-Control Study
- ClinicalTrials.gov ID
- NCT04930237
- Acronym / sponsor ID
- 013.MBSI.2021.D
- Conditions
- OIC
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI request to close study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RELISTOR is a legally marketed device and will be used off-label under the authority of a health care practitioner within a legitimate practitioner-patient relationship with the intent of the "practice of medicine".
The use of RELISTOR in the experimental group of this study meets all of the following conditions:
- is not intended to be reported to the FDA in support of a new indication for use or to support any other significant change in the labeling for the drug;
- it is not intended to support a significant change in the advertising for the product;
- it does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
- it is conducted in compliance with the requirements for IRB review and informed consent [21 CFR parts 56 and 50, respectively];
- it is conducted in compliance with the requirements concerning the promotion and sale of drugs [21 CFR 312.7]; and
- it does not intend to invoke 21 CFR 50.24
Screening and Enrollment:
Patients will undergo two levels of screening: the initial screening and a post-operative OIC screening. The initial screening will involve all 1-2 level ALIF patients in the experimental group and observational group who will be approached to participate in the study before surgery. After eligible patients agree to participate and sign the ICF, all patients will then be asked to complete the PAC-SYM instrument about their constipation symptoms over the past 2 weeks.
Patients in both groups will undergo their 1-2 level ALIF procedure and then will undergo the post-operative OIC screen/rescreen (as needed) daily for acute OIC for a maximum of 3 days (i.e., postoperative days 2 - 4). Patients who are found to have acute OIC will be designated to the experimental and observational treatment regimens accordingly to Study Treatment Regimens.
If a patient does not have acute OIC after they are rescreened on postoperative day 4, are discharged, or do not meet the inclusion criteria, will be placed in the not-constipated or post-operative screen failure group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Drug: Relistor Injectable ProductPatients who receive RELISTOR |
| Observational Group | – | Drug: Docusate Calcium, Drug: Bisacodyl, Drug: Milk of magnesia, Drug: Magnesium citrate, Drug: Senna, Drug: EnemaPatients that receive standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (22 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relistor Injectable Product12-mg RELISTOR to be administered as once-daily subcutaneous injections for 4 to 7 days | Drug | Experimental Group |
| Docusate CalciumStandard of care | Drug | Observational Group |
| BisacodylStandard of Care | Drug | Observational Group |
| Milk of magnesiaStandard of Care | Drug | Observational Group |
| Magnesium citrateStandard of Care | Drug | Observational Group |
| SennaStandard of Care | Drug | Observational Group |
| EnemaStandard of Care | Drug | Observational Group |
Primary outcome
Bowel Movement assessment
Time frame: July 2021 - April 2022
Percentage of patients with bowel movement (BM) within four hours of first RELISTOR dose or SOC bowel regimen
Post-treatment Bowel Movement
Time frame: July 2021 - April 2022
Time to Bowel Movement after first treatment
3 secondary outcomes
Patient Assessment of Constipation Symptoms (PAC-SYM)
Time frame: July 2021 - April 2022
Treatment Satisfaction Questionnaire for Medication
Time frame: July 2021 - April 2022
Bowel Function Diary
Time frame: July 2021 - April 2022
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Meyrat, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OIC, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Movement assessment (time frame: July 2021 - April 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.