CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 198 enrolled / 198 target
Drug / intervention
Ibuprofen 400 mg +1 moredrug
Likely dose
Ibuprofen 400 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/NCT04611529
NCT04611529Phase 4CompletedHigh Momentum (3.1/mo)Completion was 36mo ago
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A Randomized Study of Topical Diclofenac Versus Oral Ibuprofen for Acute Non-radicular Low Back Pain

Montefiore Medical Center·interventional·Posted Nov 2, 2020·Updated Jun 11, 2026

In Brief

A Phase 4 clinical trial evaluating Ibuprofen 400 mg and Topical diclofenac for Low Back Pain. Completed, enrolled 198 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.

Study Details

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

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedNov 2, 2020
Enrollment StartMar 2, 2021
Primary CompletionJun 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.7 years ago

Arms & Interventions

Oral ibuprofen + topical diclofenacexperimental

Oral ibuprofen 400mg Topical diclofenac 4gm

Drug: Ibuprofen 400 mgDrug: Topical diclofenac
Oral ibuprofen + topical placeboactive_comparator

Oral ibuprofen 400mg Topical placebo

Drug: Ibuprofen 400 mg
Oral placebo + topical diclofenacactive_comparator

Oral placebo Topical diclofenac 4gm

Drug: Topical diclofenac

Interventions

Ibuprofen 400 mgdrug

Ibuprofen 400mg

Topical diclofenacdrug

Diclofenac 1% gel 4gm