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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT01272934

First received: January 7, 2011

Last updated: January 15, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 7, 2011
Last Updated Date	January 15, 2013
Start Date ^ICMJE	January 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 6, 2012)	Pain on Movement [ Time Frame: 72 hours ] [ Designated as safety issue: No ] Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"
Original Primary Outcome Measures ^ICMJE (submitted: January 7, 2011)	Pain on Movement [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01272934 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 6, 2012)	Onset of Pain Relief [ Time Frame: On day 1 ] [ Designated as safety issue: No ] Onset of perceptible pain relief.
Original Secondary Outcome Measures ^ICMJE (submitted: January 7, 2011)	Onset of pain relief [ Time Frame: On day 1 ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Official Title ^ICMJE	A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Brief Summary	The purpose of this study is to evaluate the efficacy of 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Acute Ankle Sprain
Intervention ^ICMJE	Drug: Diclofenac Sodium Topical gel 1%-4 times daily Other: Placebo Topical gel-4 times daily
Study Arm (s)	Placebo Comparator: Placebo Intervention: Other: Placebo Experimental: Diclofenac sodium topical gel 1% Diclofenac sodium topical gel 1% Intervention: Drug: Diclofenac Sodium
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	205
Completion Date	August 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Male or female aged 18 years and over.Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. Injury within past 12 hours. Exclusion Criteria: Pain medication was taken within the 6 hours that precede randomization.During the past 3 months: Grade I-III sprain of the same ankle.During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01272934
Other Study ID Numbers ^ICMJE	VOSG-P-318
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis
Study Sponsor ^ICMJE	Novartis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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