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NCT04611529 · ClinicalTrials.gov registry record · Phase 4

Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

A Phase 4 study of Low Back Pain, sponsored by Montefiore Medical Center.

Completed
Registry status
Phase 4
Development phase
198
Enrollment target
1
Study location

NCT04611529 is a Phase 4 study of Low Back Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 198 participants, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04611529, a Phase 4 study of Low Back Pain, has completed, sponsored by Montefiore Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
198 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Low Back Pain

Interventions

  • DRUG Ibuprofen 400 mg
  • DRUG Topical diclofenac

Study Locations (1)

New York

  • Montefiore - New York

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2021-03-02
Est. Completion 2023-06-30
Phase Phase 4

Sponsor

Montefiore Medical Center

345 total trials

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What the Registry Record Tells You About NCT04611529

The ClinicalTrials.gov registry entry for NCT04611529 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (61% lower). The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Ibuprofen 400 mg is the first listed.

NCT04611529 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04611529 about?

NCT04611529 is a clinical study titled "Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.". 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) O...

What is the current status of trial NCT04611529?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 198 participants. The study started on 2021-03-02. Estimated completion is 2023-06-30.

What conditions does trial NCT04611529 study?

This clinical trial studies the following conditions: Low Back Pain.

What interventions are being tested in trial NCT04611529?

The interventions under investigation include: Ibuprofen 400 mg (DRUG), Topical diclofenac (DRUG).

Who is sponsoring clinical trial NCT04611529?

This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04611529 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.