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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00573768

First received: December 13, 2007

Last updated: April 18, 2012

Last verified: October 2010

History of Changes

Results First Received: July 28, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Ankle Sprain
Interventions:	Drug: Diclofenac diethylamine 2.32% gel Drug: Placebo Drug: Diclofenac diethylamine 2.32% gel / 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
Recruitment start 27 Nov 2007 Recruitment end 26 Jun 2007 Private Practices

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 (DDEA) 2.32% Gel BID	Twice daily (BID) application
DDEA 2.32% Gel OD	Once daily (OD) application of active gel and OD application of vehicle gel
Vehicle Gel	BID application

Participant Flow: Overall Study

	Diclofenac Diethylamine (DDEA) 2.32% Gel BID	DDEA 2.32% Gel OD	Vehicle Gel
STARTED	89	91	91
COMPLETED	87	89	87
NOT COMPLETED	2	2	4
Adverse Event	1	1	2
Protocol Violation	1	0	1
Withdrawal by Subject	0	1	0
Lost to Follow-up	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Diclofenac Diethylamine (DDEA) 2.32% Gel BID	Twice daily (BID) application
DDEA 2.32% Gel OD	Once daily (OD) application of active gel and OD application of vehicle gel
Vehicle Gel	BID application
Total	Total of all reporting groups

Baseline Measures

	Diclofenac Diethylamine (DDEA) 2.32% Gel BID	DDEA 2.32% Gel OD	Vehicle Gel	Total
Number of Participants [units: participants]	89	91	91	271
Age [units: years] Mean ± Standard Deviation	38.8 ± 13.7	38.2 ± 14.6	38.9 ± 14.1	38.6 ± 14.1
Gender [units: participants]
Female	49	47	46	142
Male	40	44	45	129
Region of Enrollment [units: participants]
Germany	89	91	91	271

Outcome Measures

1. Primary:

Pain on Movement on Day 5 (Change From Baseline). A Greater Change From Baseline on Day 5 Equates to a Better Outcome. [ Time Frame: change from baseline (on day 1) to 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: Sandy Hamelsky
Organization: Novartis Consumer Health
phone: +19735037258
e-mail: sandy.hamelsky@novartis.com

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00573768 History of Changes
Other Study ID Numbers:	VOPO-PE-201
Study First Received:	December 13, 2007
Results First Received:	July 28, 2010
Last Updated:	April 18, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices (BfArM)

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