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NCT02087748 · ClinicalTrials.gov registry record · Phase 4

An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS

A Phase 4 study of Pain and Delayed Onset Muscle Soreness, sponsored by Lotus Clinical Research.

Completed
Registry status
Phase 4
Development phase
24
Enrollment target
1
Study location

NCT02087748: Completed Phase 4 study of Pain and Delayed Onset Muscle Soreness, sponsored by Lotus Clinical Research.

NCT02087748 is a Phase 4 study of Pain and Delayed Onset Muscle Soreness that has completed, run by Lotus Clinical Research. The registered enrollment target is 24 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02087748, a Phase 4 study of Pain and Delayed Onset Muscle Soreness, has completed, sponsored by Lotus Clinical Research.

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

Study Summary

The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.

Primary Outcome

The primary outcome is the analgesic efficacy of Topical Voltaren® gel compared to placebo in the reduction of the pain associated with DOMS. The statistical comparison of interest will be the mean reduction in DOMS scores upon walking in the leg receiving Topical Voltaren® gel vs the leg receiving placebo over the first 24 hours post treatment. Pain intensity was assessed at predefined time points (Predose, 3, 9, 15, 21, and 24 hours after first drug administration) using an 11-point Numeric Ra

Interventions

  • DRUG Placebo
  • DRUG 1% diclofenac sodium gel

Study Locations (1)

California

  • Lotus Clinical Research, LLC - Pasadena

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2014-03
Est. Completion 2014-05
Phase Phase 4
Lotus Clinical Research

5 total trials

What the finished NCT02087748 record still lists

NCT02087748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (92% lower).

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02087748 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT02087748 about?

NCT02087748 is a clinical study titled "An Investigator Initiated, Within-Subject, Proof of Concept Study to Assess the Efficacy and Safety of Voltaren Gel in Subjects With DOMS". The purpose of this study is to evaluate analgesic efficacy of Topical Voltaren Gel (diclofenac sodium gel) 1% applied QID compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness.

What is the current status of trial NCT02087748?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2014-03. Estimated completion is 2014-05.

What conditions does trial NCT02087748 study?

This clinical trial studies the following conditions: Pain, Delayed Onset Muscle Soreness.

What interventions are being tested in trial NCT02087748?

The interventions under investigation include: Placebo (DRUG), 1% diclofenac sodium gel (DRUG).

Who is sponsoring clinical trial NCT02087748?

This trial is sponsored by Lotus Clinical Research, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02087748 being conducted?

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

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02087748's enrollment target sits among peer trials

24 325th of 374 higher than 42 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02087748, the US trial registry maintained by the National Library of Medicine. NCT02087748 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.