Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
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
1 other identifier
interventional
205
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2011
Shorter than P25 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
January 15, 2013
CompletedJanuary 24, 2013
January 1, 2013
7 months
January 7, 2011
August 7, 2012
January 15, 2013
Conditions
Keywords
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 (1)
Onset of Pain Relief
On day 1
Study Arms (2)
Placebo
PLACEBO COMPARATORDiclofenac sodium topical gel 1%
EXPERIMENTALDiclofenac sodium topical gel 1%
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (6)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Leader
- Organization
- Novartis Consumer Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 10, 2011
Study Start
January 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 24, 2013
Results First Posted
January 15, 2013
Record last verified: 2013-01