Efficacy and safety of Diclofenac for Treatment of Pain and inflammation of Acute Soft Tissue Injury/ Ankle Sprain Clinical study to evaluate the efficacy and safety of a 2% Diclofenac cutaneous solution vs. placebo in the treatment of acute uncomplicatedunilateral ankle sprai
- Conditions
- Treatment of pain and Inflammation associated Acute Soft Tissue Injury/Ankle SprainMedDRA version: 18.1Level: LLTClassification code 10002549Term: Ankle sprainSystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2014-005574-11-DE
- Lead Sponsor
- uvo Research GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Experiencing an acute grade I or II sprain of the lateral ankle as assessed by the investigator within 12hrs of injury.
2. Male or female aged 18 – 75 years
3. Have POM of > 50mm on a 100mm visual analogue scale (VAS) and no use of pain medication within 12hrs preceding randomization
4. Willing and able to provide informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
1.Any concurrent injury affecting the lower extremities that is painful at rest or on movement that could affect mobilization of the patient
2.Use of topical analgesics or anti-inflammatories during the previous 30 days in the affected ankle
3.A grade I sprain of the same ankle within 3 months
4.A grade II or III sprain or any other significant injury or surgery of the same ankle/foot within 6 months of study start
5.Pain or instability in ankle attributable to previous ankle sprain
6.Any other trauma or ankle sprain attributed to a known disease affecting the ligaments.
7.Subjects with known hypersensitivity to diclofenac, aspirin (acetylsalicylic acid [ASA]) or any other NSAID, dimethyl sulfoxide (DMSO), or ethanol. This includes subjects exhibiting aspirin or other NSAID-induced symptoms, including bronchospasm, rhinitis, and urticaria or other NSAID-induced allergic symptoms.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is:<br>To assess the efficacy of diclofenac sodium 2% w/w cutaneous solution for the treatment of Pain and Inflammation associated with acute soft tissue injury/ankle sprain;Secondary Objective: To assess the safety and tolerability of diclofenac sodium 2% w/w cutaneous solution for treatment of Pain and Inflammation associated with acute soft tissue injury/ankle sprain.<br><br><br><br>;Primary end point(s): Change in Pain on movement (POM) from day 1 to day 5;Timepoint(s) of evaluation of this end point: Day 1 to 5 of the POM
- Secondary Outcome Measures
Name Time Method