- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272934
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Ankle Sprain
January 15, 2013 updated by: Novartis
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
205
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
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
- NCH investigative site, Munich, Germany.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Topical gel-4 times daily
|
EXPERIMENTAL: Diclofenac sodium topical gel 1%
|
Topical gel 1%-4 times daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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"
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset of Pain Relief
Time Frame: On day 1
|
Onset of perceptible pain relief.
|
On day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
January 7, 2011
First Submitted That Met QC Criteria
January 7, 2011
First Posted (ESTIMATE)
January 10, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
January 24, 2013
Last Update Submitted That Met QC Criteria
January 15, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Wounds and Injuries
- Leg Injuries
- Sprains and Strains
- Ankle Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- VOSG-P-318
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Ankle Sprain
-
Sen-wei LuRecruiting
-
Spaarne GasthuisCompletedAnkle Injuries | Acute Ankle Sprain | Ankle Ligament RuptureNetherlands
-
Strategic Science & Technologies, LLCCompletedAcute Ankle SprainUnited States
-
Kowa Research Institute, Inc.TerminatedAcute Pain From Ankle Sprain or StrainUnited States
-
Decathlon SEEFOR, FranceTerminatedAnkle Sprain 1St Degree | Ankle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeFrance
-
National Defense Medical Center, TaiwanTri-Service General HospitalRecruitingAnkle Sprain 2Nd Degree | Ankle Sprain 3Rd DegreeTaiwan
-
Instituto Mexicano del Seguro SocialCompletedAnkle Sprain | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeMexico
-
Université Catholique de LouvainCompletedAnkle Sprain 1St Degree | Ankle Sprain 2Nd DegreeBelgium
-
University GhentCompletedAcute Ankle DistortionBelgium
-
Vanderbilt University Medical CenterRecruitingMusculoskeletal Injury | Ankle Sprain 1St Degree | Ankle Sprain 2Nd DegreeUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States