CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 120 enrolled
Drug / intervention
Acetaminophen +3 moredrug
Likely dose
Ibuprofen 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03554018
NCT03554018Phase 3Completed

Ibuprofen With or Without Acetaminophen for Acute, Non-radicular Low Back Pain: A Randomized Trial

Montefiore Medical Center·interventional·Posted Jun 12, 2018·Updated Feb 28, 2024

In Brief

A Phase 3 clinical trial evaluating Acetaminophen, Ibuprofen 600 mg, and 2 other interventions for Low Back Pain. Completed, enrolled 120 participants across 1 site.

Detailed Summary

This is a randomized clinical trial comparing two interventions for acute low back pain: 1. Ibuprofen + acetaminophen 2. Ibuprofen + placebo Participants will include patients who present to an emergency room for management of low back pain. Medication will be dispensed to participants at the time of emergency room discharge. Data will be collected from participants by telephone for 1 week.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 12, 2018
Enrollment StartOct 16, 2018
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.1 years ago

Interventions

Acetaminophendrug

Acetaminophen 500-1000mg every 6 hours

Ibuprofen 600 mgdrug

Ibuprofen 600mg every 6 hours

Educational interventionbehavioral

Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)

Placebo oral capsuledrug

To match acetaminophen, patients will take one or two capsules every 6 hours