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NCT01255423 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
206
Enrollment target

NCT01255423 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 206 participants.

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The verdict

NCT01255423, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
206 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Interventions

  • DRUG Placebo
  • DRUG Diclofenac sodium topical gel 1%

Trial Details

FieldValue
Enrollment Target 206 participants
Start Date 2010-11
Est. Completion 2011-06
Phase Phase 3

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT01255423

The ClinicalTrials.gov registry entry for NCT01255423 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

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

NCT01255423 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01255423 about?

NCT01255423 is a clinical study titled "Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain". The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

What is the current status of trial NCT01255423?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2010-11. Estimated completion is 2011-06.

What interventions are being tested in trial NCT01255423?

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

Who is sponsoring clinical trial NCT01255423?

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

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.