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

Primary Purpose

Ankle Sprain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Diclofenac sodium topical gel 1%
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring Ankle sprain, soft tissue injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac sodium topical gel 1%

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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"
Onset of Pain Relief
Onset of perceptible pain relief
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.
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.

Full Information

First Posted
December 1, 2010
Last Updated
September 3, 2012
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01255423
Brief Title
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprain
Keywords
Ankle sprain, soft tissue injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac sodium topical gel 1%
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac sodium topical gel 1%
Intervention Description
Diclofenac sodium topical gel 1%, 4 times daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, 4 times daily
Primary Outcome Measure Information:
Title
Pain on Movement
Description
Pain on movement at 72 hours assessed on a 100 mm visual analog scale with anchors at 0= "No pain" and 100= "Extreme pain"
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Pain on Movement
Description
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"
Time Frame
24 hours and 7 days
Title
Onset of Pain Relief
Description
Onset of perceptible pain relief
Time Frame
Day 1
Title
Tenderness
Description
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.
Time Frame
Change from baseline at 24 and 72 hours, 7 days
Title
Ankle Joint Function
Description
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.
Time Frame
24 and 72 hours, 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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). Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Aventura
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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