Opioid Analgesic Reduction Study (OARS) - Pilot

NCT05283499 | Completed Phase 3 Results FDA Drug

• 1 other identifier: Pro2020001891
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to test protocols being developed for the conduct of a large sale multi-site clinical trial which will compare opioids to non-opioids for managing post-surgical impacted 3rd molar extraction pain.

Conditions

Post Operative Pain

Keywords

Opioids; Pain Management; Analgesics

Outcome Measures

Primary Outcomes (3)

• Pain Level

  Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain imaginable)

  1st day

• Pain Level

  Average Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

  Average for the 1st and 2nd day

• Pain Level

  Pain (self reported by subject) rated on numeric rating scale (0=no pain, 10=worst pain

  Average for the first seven days post surgery

Secondary Outcomes (9)

• Sleep Quality

  1st night

• Sleep Quality

  Average for the 1st and 2nd night

• Sleep Quality

  Average for the 1st, 2nd and 3rd night

• Sleep Quality

  Average for the first seven nights post surgery

• Pain Interference Scale (Patient Report Outcomes Measurement Information System - PROMIS 6b )

  1st day

Study Arms (2)

Opioid

ACTIVE COMPARATOR

Combination analgesic of hydrocodone 5mg/acetaminophen350 mg

Drug: OPIOID

Non-Opioid

ACTIVE COMPARATOR

Combination analgesic of ibuprofen 400mgacademinophen 350mg

Drug: NON-OPIOID

Interventions

OPIOID DRUG

Analgesic assignment

Also known as: Opioid containing analgesic

Opioid

NON-OPIOID DRUG

Analgesic assignment

Also known as: Non-opioid contains analgesic

Non-Opioid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult men and non-pregnant women who are at least 18 years of age, who are able to refrain from driving or operating heavy machinery while taking the study medication will be able to participate.
• Subjects who are English speaking and are able to provide consent will be considered.
• Subjects must be in generally good health and able to take ibuprofen, paracetamol (acetaminophen), and hydrocodone.

You may not qualify if:

• Subjects who self-report the following history will be excluded from participating:
• Individual under the age of 18
• History of gastrointestinal bleeding and/or peptic ulcer
• History of renal disease (excluding kidney stones)
• History of hepatic disease
• History of bleeding disorder
• History of respiratory depression
• Any prior respiratory effect of an opioid or other anesthetic drug that required respiratory support postoperatively
• Active or untreated asthma
• History of known allergic reaction to ibuprofen, acetaminophen, hydrocodone, and/or anesthesia
• Currently taking any of the following medications:
• CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), which may increase plasma concentrations of hydrocodone bitartrate and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression
• CNS depressants.
• Consumes 3 or more alcoholic drinks every day and/or has a history of alcoholism
• History of drug or alcohol abuse (excludes marijuana use)

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• University of Illinois at Chicago: collaborator
• University of Maryland, Baltimore: collaborator
• University of Michigan: collaborator
• University of Rochester: collaborator

Study Sites (5)

University of Illinois Chicago

Chicago, Illinois, 60607, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Analgesics, Opioid; Analgesics, Non-Narcotic

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Cecile A. Feldman
• Organization: Rutgers University School of Dental Medicine

feldman@rutgers.edu

973-972-4634

Study Officials

• Janine Fredericks-Younger, DMD

  Rutgers School of Dental Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Analgesic is formulate in capsules. Both OPIOID and NON-OPIOID analgesic formulas are packaged in the same capsules
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean, Rutgers School of dental Medicine

Model Details: A double-blind stratified randomized clinical trial is being conduct on the management of post-surgical pain after extraction of impacted third mandibular molars Subjects will be randomly assigned to either the OPIOID or NON-OPIOID group.

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 17, 2022
• Study Start: July 6, 2020
• Primary Completion: March 12, 2021
• Study Completion: March 26, 2021
• Last Updated: June 6, 2023
• Results First Posted: July 13, 2022

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available after publication of primary and secondary outcomes. Data will be available for 3 years.
• Access Criteria: Requester must have a valid e-mail address.

Locations

US (5)