Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

This study has been completed.

Study NCT00955513 Information provided by Novartis

First Received on August 7, 2009. Last Updated on January 27, 2011 History of Changes

Results First Received: December 1, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Grade I/II Ankle Sprain
Interventions:	Drug: diclofenac diethylamine gel 2.32% Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
6 centers in Germany. Recruitment commenced in July 2009 and completed in December 2009.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day	drug
Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day	drug
Placebo. Applied 3 Times a Day.	placebo

Participant Flow: Overall Study

	Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day	Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day	Placebo. Applied 3 Times a Day.
STARTED	80	80	82
COMPLETED	79	78	79
NOT COMPLETED	1	2	3

Baseline Characteristics

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Reporting Groups

	Description
Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day	drug
Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day	drug
Placebo. Applied 3 Times a Day.	placebo

Baseline Measures

	Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day	Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day	Placebo. Applied 3 Times a Day.	Total
Number of Participants [units: participants]	80	80	82	242
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	80	77	81	238
>=65 years	0	3	1	4
Age [units: years] Mean ± Standard Deviation	30.9 ± 11.4	32.2 ± 13.7	34.0 ± 12.9	32.4 ± 12.7
Gender [units: participants]
Female	31	31	28	90
Male	49	49	54	152
Region of Enrollment [units: participants]
Germany	80	80	82	242

Outcome Measures

1. Primary:

Measure: Pain on Movement on Day 5 (Change From Baseline). [ Time Frame: baseline and day 5 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Clinical Project Leader Pain category
Organization: Novartis Consumer Health
phone: +41223635528

No publications provided

Responsible Party:	Novartis Consumer Health SA
ClinicalTrials.gov Identifier:	NCT00955513 History of Changes
Other Study ID Numbers:	VOPO-P-307
Study First Received:	August 7, 2009
Results First Received:	December 1, 2010
Last Updated:	January 27, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices (BfArM)