RELISTOR's Effects on Opioid-Induced Constipation

NCT04930237 | Withdrawn

• 1 other identifier: 013.MBSI.2021.D
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

OIC

Outcome Measures

Primary Outcomes (2)

• Bowel Movement assessment

  Percentage of patients with bowel movement (BM) within four hours of first RELISTOR dose or SOC bowel regimen

  July 2021 - April 2022

• Post-treatment Bowel Movement

  Time to Bowel Movement after first treatment

  July 2021 - April 2022

Secondary Outcomes (3)

• Patient Assessment of Constipation Symptoms (PAC-SYM)

  July 2021 - April 2022

• Treatment Satisfaction Questionnaire for Medication

  July 2021 - April 2022

• Bowel Function Diary

  July 2021 - April 2022

Study Arms (2)

Experimental Group

Patients who receive RELISTOR

Drug: Relistor Injectable Product

Observational Group

Patients that receive standard of care

Drug: Docusate Calcium; Drug: Bisacodyl; Drug: Milk of magnesia; Drug: Magnesium citrate; Drug: Senna; Drug: Enema

Interventions

Relistor Injectable Product DRUG

12-mg RELISTOR to be administered as once-daily subcutaneous injections for 4 to 7 days

Experimental Group

Bisacodyl DRUG

Standard of Care

Observational Group

Docusate Calcium DRUG

Standard of care

Observational Group

Milk of magnesia DRUG

Standard of Care

Observational Group

Magnesium citrate DRUG

Standard of Care

Observational Group

Senna DRUG

Standard of Care

Observational Group

Enema DRUG

Standard of Care

Observational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Moody Brain and Spine Institute, Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Interventions

Dioctyl Sulfosuccinic Acid; Bisacodyl; Magnesium Hydroxide; magnesium citrate; Sennosides; Enema

Intervention Hierarchy (Ancestors)

Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Magnesium Compounds; Senna Extract; Anthraquinones; Anthrones; Anthracenes; Polycyclic Aromatic Hydrocarbons; Quinones; Polycyclic Compounds; Glycosides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Drug Therapy; Therapeutics

Study Officials

• Richard Meyrat, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 18, 2021
• Study Start: July 1, 2021
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: March 23, 2026

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)