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NCT02271854 · ClinicalTrials.gov registry record · Phase 3

A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
102
Enrollment target

NCT02271854: Completed Phase 3 study, sponsored by Novartis.

NCT02271854 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 102 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02271854, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
102 participants
Enrollment target

Study Summary

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

Primary Outcome

The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i

Interventions

  • DRUG Placebo
  • DRUG Diclofenac sodium gel 1%

Trial Details

FieldValue
Enrollment Target 102 participants
Start Date 2014-10
Est. Completion 2014-12
Phase Phase 3
Novartis

265 total trials

What the finished NCT02271854 record still lists

NCT02271854 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02271854 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02271854 about?

NCT02271854 is a clinical study titled "A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness". This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

What is the current status of trial NCT02271854?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2014-10. Estimated completion is 2014-12.

What interventions are being tested in trial NCT02271854?

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

Who is sponsoring clinical trial NCT02271854?

This trial is sponsored by Novartis, which has 265 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02271854's enrollment target sits among peer trials

102 1676th of 2000 higher than 321 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT02271854, the US trial registry maintained by the National Library of Medicine. NCT02271854 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.