Treatment of pain and Inflammation associated Acute Soft Tissue Injury/Ankle Sprain MedDRA version: 18.1 Level: LLT Classification code 10002549 Term: Ankle sprain System Organ Class: 100000004863
Conditions
Interventions
Product Name: Pennsaid 2 % cutanous solution
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: Diclofenac
CAS Number: 15307-79-6
Other descriptive name: Diclofenac Sodium
Concentration unit
Sponsors
Nuvo Research GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: 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. ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in POM from day 1 to day 3 and from day 1 to day 8 Response to treatment: Frequency of Meaningful Improvement in POM (50% reduction or more in POM from day 1) Number Needed To Treat computed for meaningful pain relief (50% reduction or more in POM from Day 1) Time to meaningful pain relief (time to 50% reduction in POM from Day 1) PAR on days 3,5, and 8 Tenderness (algometer) on days 3,5, and 8 Ankle joint function (Karlsson Scoring Scale) on days 3, 5, and 8 Swelling measured using the “figure-of-eight” method on days 3, 5, and 8 Rescue Medication use PGAB and PGAS at day 5 and day 8. Exploratory efficacy endpoints: •Cumulative proportional responders analysis (cumulative distribution of percent decrease from day 1 in POM) •Two alternative definitions of meaningful pain relief will also be analysed: -A reduction in POM of 40mm from Day 1 -A POM of < 30mm ;Timepoint(s) of evaluation of this end point: 1. day 1,3 , 5 and 8: POM, PAR, tenderness, ankle swelling and ankle function 2. all days use of rescue medication | — |
Countries
Germany
Contacts
Public ContactBundesinstitut
Bundesinstitut für Arzneimittel und Medizinprodukte
Outcome results
None listed