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

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ClinicalTrials.gov Identifier: NCT01255423
Recruitment Status : Completed
First Posted : December 7, 2010
Results First Posted : October 4, 2012
Last Update Posted : October 4, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE December 1, 2010
First Posted Date  ICMJE December 7, 2010
Results First Submitted Date  ICMJE June 8, 2012
Results First Posted Date  ICMJE October 4, 2012
Last Update Posted Date October 4, 2012
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
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"
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
Pain on Movement [ Time Frame: 72 hours ]
Pain on movement at 72 hours
Change History Complete list of historical versions of study NCT01255423 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2012)
  • Pain on Movement [ Time Frame: 24 hours and 7 days ]
    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 [ Time Frame: Day 1 ]
    Onset of perceptible pain relief
  • Tenderness [ Time Frame: Change from baseline at 24 and 72 hours, 7 days ]
    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 [ Time Frame: 24 and 72 hours, 7 days ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2010)
  • Pain on Movement [ Time Frame: 24 hours and 7 days ]
    Pain on movement at 24 hours and 7 days
  • Onset of Pain Relief [ Time Frame: Day 1 ]
    Onset of pain relief on Day 1 of study drug use
  • Tenderness [ Time Frame: 24 and 72 hours, 7 days ]
    Tenderness at 24 and 72 hours and 7 days
  • Ankle Joint Function [ Time Frame: 24 and 72 hours, 7 days ]
    Ankle joint function at 24 and 72 hours and 7 days
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankle Sprain
Intervention  ICMJE
  • Drug: Diclofenac sodium topical gel 1%
    Diclofenac sodium topical gel 1%, 4 times daily
  • Drug: Placebo
    Placebo, 4 times daily
Study Arms  ICMJE
  • Experimental: Diclofenac sodium topical gel 1%
    Intervention: Drug: Diclofenac sodium topical gel 1%
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2012)
206
Original Estimated Enrollment  ICMJE
 (submitted: December 6, 2010)
200
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01255423
Other Study ID Numbers  ICMJE 197-P-320
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Novartis
PRS Account Novartis
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP