RELISTOR's Effects on Opioid-Induced Constipation

OIC Clinical Trial

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

Status Withdrawn

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Constipation
• OIC
• Opioid-Induced Constipation

• NCT number: NCT04930237
• Study type: Observational
• Source: Methodist Health System
• Status: Withdrawn
• Start date: July 1, 2021
• Completion date: April 22, 2022