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

NCT01255423 | Completed Phase 3 Results

• 1 other identifier: 197-P-320
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Ankle Sprain

Keywords

Ankle sprain, soft tissue injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Pain on Movement

  24 hours and 7 days

• Onset of Pain Relief

  Day 1

• Tenderness

  Change from baseline at 24 and 72 hours, 7 days

• Ankle Joint Function

  24 and 72 hours, 7 days

Study Arms (2)

Diclofenac sodium topical gel 1%

EXPERIMENTAL

Drug: Diclofenac sodium topical gel 1%

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diclofenac sodium topical gel 1% DRUG

Diclofenac sodium topical gel 1%, 4 times daily

Diclofenac sodium topical gel 1%

Placebo DRUG

Placebo, 4 times daily

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis: lead

Study Sites (9)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Aventura, Florida, United States

Location

Unknown Facility

Hialeah, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Berlin, New Jersey, United States

Location

Unknown Facility

Columbia, South Carolina, United States

Location

Unknown Facility

El Paso, Texas, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Ankle Injuries; Soft Tissue Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Results Point of Contact

• Title: Clinical Project Leader
• Organization: Novartis Consumer Health

0041223635528

Study Officials

• Study Director

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 7, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 4, 2012
• Results First Posted: October 4, 2012

Record last verified: 2012-09

Locations

US (9)