Back to resultsEfficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
Primary Purpose
Acute Ankle Sprain
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Diclofenac Sodium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ankle Sprain focused on measuring Ankle Sprain, soft tissue injury
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).
Sites / Locations
- NCH investigative site
- NCH investigative site
- NCH investigative site
- NCH investigative site
- NCH investigative site
- NCH investigative site, Munich, Germany.
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Diclofenac sodium topical gel 1%
Arm Description
Diclofenac sodium topical gel 1%
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
Onset of Pain Relief
Onset of perceptible pain relief.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01272934
Brief Title
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four 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 Four Times Daily in Subjects With Acute Ankle Sprain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ankle Sprain
Keywords
Ankle Sprain, soft tissue injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Diclofenac sodium topical gel 1%
Arm Type
Experimental
Arm Description
Diclofenac sodium topical gel 1%
Intervention Type
Drug
Intervention Name(s)
Diclofenac Sodium
Intervention Description
Topical gel 1%-4 times daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Topical gel-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
Onset of Pain Relief
Description
Onset of perceptible pain relief.
Time Frame
On day 1
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).
Facility Information:
Facility Name
NCH investigative site
City
Bad Nauheim
Country
Germany
Facility Name
NCH investigative site
City
Brühl
Country
Germany
Facility Name
NCH investigative site
City
Cologne
Country
Germany
Facility Name
NCH investigative site
City
Essen
Country
Germany
Facility Name
NCH investigative site
City
Gilching
Country
Germany
Facility Name
NCH investigative site, Munich, Germany.
City
Munich
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
We'll reach out to this number within 24 hrs