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Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

NCT ID: NCT00573768

Last Updated: 2012-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-07-31

Brief Summary

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This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

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Detailed Description

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Conditions

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Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Diclofenac diethylamine 2.32% gel

Intervention Type DRUG

Diclofenac diethylamine 2.32% gel twice daily

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle 2 times daily

3

Group Type ACTIVE_COMPARATOR

Diclofenac diethylamine 2.32% gel / Placebo

Intervention Type DRUG

Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Interventions

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Diclofenac diethylamine 2.32% gel

Diclofenac diethylamine 2.32% gel twice daily

Intervention Type DRUG

Placebo

Vehicle 2 times daily

Intervention Type DRUG

Diclofenac diethylamine 2.32% gel / Placebo

Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Acute sprain of the ankle
* Injury within past 48 hours.

Exclusion Criteria

* Pain medication taken since the injury
* Pain or instability in the same ankle due to previous ankle sprain or any other trauma.
* Ankle sprain due to a known disease affecting the ligaments
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Baltzer

Role: PRINCIPAL_INVESTIGATOR

Locations

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Novartis Investigative Site

Bad Bramstedt, , Germany

Site Status

Novartis Investigative Site

Bad Nauheim, , Germany

Site Status

Novartis Investigative Site

Bad Zwischenahn, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Bochum, , Germany

Site Status

Novartis Investigative Site

Dortmund, , Germany

Site Status

Novartis Investigative Site

Dresden, , Germany

Site Status

Novartis Investigative Site

Düsseldorf, , Germany

Site Status

Novartis Investigative Site

Eichstätt, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hammelburg, , Germany

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Novartis Investigative Site

Karlsruhe, , Germany

Site Status

Novartis Investigative Site

Kaufbeuren, , Germany

Site Status

Novartis Investigative Site

Lambrecht/Pfalz, , Germany

Site Status

Novartis Investigative Site

Leipzig, , Germany

Site Status

Novartis Investigative Site

Meersburg, , Germany

Site Status

Novartis Investigative Site

Munich, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

München, , Germany

Site Status

Novartis Investigative Site

Neustadt/Aisch, , Germany

Site Status

Novartis Investigative Site

Siegen, , Germany

Site Status

Novartis Investigative Site

Stockach, , Germany

Site Status

Countries

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Germany

Other Identifiers

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VOPO-PE-201

Identifier Type: -

Identifier Source: org_study_id

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