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

• ClinicalTrials.gov Identifier: NCT01272934
• Recruitment Status: Completed
• First Posted: January 10, 2011
• Results First Posted: January 15, 2013
• Last Update Posted: January 24, 2013
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acute Ankle Sprain	Drug: Diclofenac Sodium; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 205 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: January 2011
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Other: Placebo; Topical gel-4 times daily
Experimental: Diclofenac sodium topical gel 1%; Diclofenac sodium topical gel 1%	Drug: Diclofenac Sodium; Topical gel 1%-4 times daily

Outcome Measures

Primary Outcome Measures :

1. Pain on Movement [ Time Frame: 72 hours ]
   Pain on Movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0="No pain" and 100= "Extreme pain"

Secondary Outcome Measures :

1. Onset of Pain Relief [ Time Frame: On day 1 ]
   Onset of perceptible pain relief.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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).

Contacts and Locations

Locations

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, Germany

Sponsors and Collaborators

Novartis

More Information

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT01272934
• Other Study ID Numbers: VOSG-P-318
• First Posted: January 10, 2011
• Results First Posted: January 15, 2013
• Last Update Posted: January 24, 2013
• Last Verified: January 2013

Keywords provided by Novartis:

Ankle Sprain, soft tissue injury

Additional relevant MeSH terms:

Sprains and Strains; Ankle Injuries; Wounds and Injuries; Leg Injuries; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action