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

Ankle Sprain Clinical Trial

Official title:

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 4 Times Daily in Subjects With Acute Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255423
• Other study ID #: 197-P-320
• Status: Completed
• Phase: Phase 3
• First received: December 1, 2010
• Last updated: September 3, 2012
• Start date: November 2010
• Est. completion date: June 2011

Study information

• Verified date: September 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Male or female aged 18 years and over.

2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.

3. Injury within past 12 hours.

Exclusion criteria:

1. Pain medication was taken within the 6 hours that precede randomization.

2. During the past 3 months: Grade I-III sprain of the same ankle.

3. 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.

4. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.

5. 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).

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprain

Intervention

Drug:
• Diclofenac sodium topical gel 1%
Diclofenac sodium topical gel 1%, 4 times daily
• Placebo
Placebo, 4 times daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on Movement	Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"	72 hours	No
Secondary	Pain on Movement	Pain on movement at 24 hours and 7 days assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"	24 hours and 7 days	No
Secondary	Onset of Pain Relief	Onset of perceptible pain relief	Day 1	No
Secondary	Tenderness	Tenderness at 24 and 72 hours and 7 days. Change from baseline. Tenderness was measured by a calibrated algometer in order to quantify the pressure pain threshold, a measure of tenderness.	Change from baseline at 24 and 72 hours, 7 days	No
Secondary	Ankle Joint Function	Ankle joint function score (Karlsson Scoring scale which ranges from 0 "worst possible score" to 90 "best possible score")at 24 and 72 hours and 7 days.	24 and 72 hours, 7 days	No