RELISTOR's Effects on Opioid-Induced Constipation

Sponsor

Methodist Health System (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04930237

Collaborator

(none)

Enrollment

Location

9.7

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
OIC	Drug: Relistor Injectable Product Drug: Docusate Calcium Drug: Bisacodyl Drug: Milk of magnesia Drug: Magnesium citrate Drug: Senna Drug: Enema

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

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

RELISTOR's Effects on Opioid-Induced Constipation in Postoperative 1-2 Level Anterior Lumbar Interbody Fusion Patients: A Case-Control Study

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Apr 22, 2022

Actual Study Completion Date :

Apr 22, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental Group Patients who receive RELISTOR	Drug: Relistor Injectable Product 12-mg RELISTOR to be administered as once-daily subcutaneous injections for 4 to 7 days
Observational Group Patients that receive standard of care	Drug: Docusate Calcium Standard of care Drug: Bisacodyl Standard of Care Drug: Milk of magnesia Standard of Care Drug: Magnesium citrate Standard of Care Drug: Senna Standard of Care Drug: Enema Standard of Care

Arm

Intervention/Treatment

Experimental Group

Patients who receive RELISTOR

Drug: Relistor Injectable Product

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

Observational Group

Patients that receive standard of care

Drug: Docusate Calcium

Standard of care

Drug: Bisacodyl

Standard of Care

Drug: Milk of magnesia

Standard of Care

Drug: Magnesium citrate

Standard of Care

Drug: Senna

Standard of Care

Drug: Enema

Standard of Care

Outcome Measures

Primary Outcome Measures

Bowel Movement assessment [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 [July 2021 - April 2022]
Time to Bowel Movement after first treatment

Secondary Outcome Measures

Patient Assessment of Constipation Symptoms (PAC-SYM) [July 2021 - April 2022]
to measure patient's self-reported experience of symptoms and symptom severity in constipation pre-operatively and at patients post-operative follow-up
Treatment Satisfaction Questionnaire for Medication [July 2021 - April 2022]
to measure patients' satisfaction with medication
Bowel Function Diary [July 2021 - April 2022]
Daily Assessment Module: to measure constipation symptoms experienced in the past 24 hours during hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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