NCT04122443

Brief Summary

This is an emergency department based randomized study of oxycodone/ acetaminophen versus acetaminophen alone for patients with acute musculoskeletal pain refractory to ibuprofen

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
393

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

October 8, 2019

Results QC Date

November 6, 2023

Last Update Submit

February 26, 2024

Conditions

Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Pain Assessment

    Stage 1 (Open label): No Outcome Measures assessed Stage 2 (Double blinded): Change in Pain Assessment from baseline was determined using the Numeric Rating Scale (NRS) for evaluating pain. The rating was verbalized, and the subject was asked to estimate current pain intensity on an 11-point scale, where 0 indicated no pain at all and 10 indicated the worst imaginable pain. Positive mean changes in NRS scores were associated with increased pain relief.

    2 hours following treatment

Secondary Outcomes (4)

  • Sustained Pain Relief

    Up to 48 hours following medication administration

  • Adequacy of Analgesia

    2 hours following treatment

  • Satisfaction With Medication

    2 hours following treatment

  • Medication-related Adverse Events

    2 hours following treatment

Study Arms (2)

Acetaminophen

ACTIVE COMPARATOR

Acetaminophen alone

Drug: Acetaminophen

Oxycodone/ acetaminophen

ACTIVE COMPARATOR

Oxycodone + acetaminophen

Drug: AcetaminophenDrug: Oxycodone

Interventions

AcetaminophenDRUG

Acetaminophen 650mg

AcetaminophenOxycodone/ acetaminophen
OxycodoneDRUG

Oxycodone 10mg

Oxycodone/ acetaminophen

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
  • Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity

You may not qualify if:

  • Use of an non-steroidal anti-inflammatory drug within the previous six hours
  • Use of acetaminophen within the previous six hours
  • Use of an opioid within the previous ten days
  • Chronic pain, defined as any pain on \>50% of days for at least 3 months prior to onset of acute pain
  • Gout

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

AcetaminophenOxycodone

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Dr. Benjamin Friedman
Organization
Montefiore Medical Center
befriedm@montefiore.org
718-920-6626

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

December 1, 2019

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

February 28, 2024

Results First Posted

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)