Analgesic Efficacy of (MSIR)/Acetaminophen vs. Oxycodone/Acetaminophen (Percocet)

NCT03088826 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2017-01-05
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Oxycodone and Hydrocodone are the most commonly used oral opioid analgesics in the emergency department and in outpatient settings. Both medications have a very high potential for abuse due to the prominence of the euphoric effect (abuse liability) and relative lack of "bad "or "negative" effects (likeability). The highly addictive properties of these medications lead to recurrent ED visits for repetitive dosing and prescribing that may lead to abuse, misuse, development of dependence and addiction, and, most importantly, death due to overdose. In contrast, several research papers demonstrated that administration of MSIR results in similar analgesic efficacy to Oxycodone and Hydrocodone but with significantly less euphoric and rewarding associated effects. In addition, consumption of large doses of MSIR leads to dysphoria, vomiting and sedation ("negative effects"). To the investigators' knowledge, there are no randomized controlled trials in the ED that directly compared analgesic efficacy of MSIR to Percocet

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Pain Reduction at 60 Minutes (Baseline Pain Score - Pain Score at 60 Minutes)

  The reduction of pain at 60 minutes from baseline: The pain scale ranges from 0 to 10 with 0 being no pain, 5 being moderate pain and 10 being very severe pain.

  60 minutes

Study Arms (2)

MSIR and Acetaminophen Group

ACTIVE COMPARATOR

The patients in this group will receive 1 tablet 15mg PO morphine sulfate immediate release combined with 650mg of Acetaminophen

Drug: Morphine Sulfate; Drug: Acetaminophen

Oxycodone and Acetaminophen Group

ACTIVE COMPARATOR

The patients in this group will receive 1 tablet 10mg Oxycodone combined with 650mg of Acetaminophen

Drug: Oxycodone; Drug: Acetaminophen

Interventions

Morphine Sulfate DRUG

15mg PO morphine sulfate

MSIR and Acetaminophen Group

Oxycodone DRUG

10mg Oxycodone

Oxycodone and Acetaminophen Group

Acetaminophen DRUG

650 mg Acetaminophen

MSIR and Acetaminophen Group; Oxycodone and Acetaminophen Group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ages 18-64,
• present to the Emergency department with moderate-to-severe acute pain that warrants an oral opioid analgesic.
• pain score is above 5 and are deemed to require oral opioid at the discretion of the attending physician.
• Painful conditions will include but will not be limited to acute traumatic/non-traumatic musculoskeletal pain, renal colic pain, dental pain.

You may not qualify if:

• age \<18, age \>64,
• subjects who received long acting opioids within 24 hours of presenting to ED
• received short acting analgesics within 4 hours,
• chronic pain,
• pregnant patients,
• patient refusal,
• altered mental status,
• known allergy to either morphine or oxycodone or acetaminophen,
• history of substance and opioid abuse,
• unstable vital signs, acute psychosis or incarceration.
• subjects who received long acting opioids within 24 hours of presenting to ED;
• chronic pain"

Sponsors & Collaborators

• Antonios Likourezos: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Morphine; Oxycodone; Acetaminophen

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Sergey Motov
• Organization: Maimonides Medical Center

smotov@maimonidesmed.org

718283600

Study Officials

• Sergey Motov, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 23, 2017
• Study Start: August 18, 2017
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: March 14, 2022
• Results First Posted: March 14, 2022

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)