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

Acute 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 Four Times Daily in Subjects With Acute Ankle Sprain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272934
• Other study ID #: VOSG-P-318
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2011
• Last updated: January 15, 2013
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Ankle Sprain
• Ankle Injuries

Intervention

Drug:
• Diclofenac Sodium
Topical gel 1%-4 times daily

Other:
• Placebo
Topical gel-4 times daily

Locations

Country	Name	City	State
Germany	NCH investigative site	Bad Nauheim
Germany	NCH investigative site	Brühl
Germany	NCH investigative site	Cologne
Germany	NCH investigative site	Essen
Germany	NCH investigative site	Gilching
Germany	NCH investigative site, Munich, Germany.	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

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	Onset of Pain Relief	Onset of perceptible pain relief.	On day 1	No