Health Condition 1: S934- Sprain of ankle
Conditions
Interventions
Intervention1: Test product (T): Diclofenac diethylamine 2.32% w/w gel: The participants will be
instructed to apply
approximately 4 grams
(approximately 4.5-inch length
of gel) of assigned study
trea
Sponsors
JAMP Pharma Corporation
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female participant, greater than or equal to 18 years and Less than or equal to 65 years of age at the time of enrolment. 2.Diagnosed by physical examination with acute sprain of lateral ankle, Grade I and II (as classified by The West Point Ankle Grading System). 3.Injury leading to sprain must have occurred within 24 hours prior to enrolment. 4.Pain on movement of injured area [measured on a 100 mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain)] greater than or equal to 50 mm immediately prior to randomization. Note: Pain on movement on a Visual Analogue Scale (VAS) will be registered by the participant lying down while the investigator holds the injured leg at 45° and performs gentle supination of the injured ankle to reach an angle of approx. 30°. 5.Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits. 6.Willingness to avoid use of other topical or systemic analgesic or anti-inflammatory medications during the study period, except permitted rescue medication (Paracetamol 650 mg, or other Investigator-approved rescue medication). 7.Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed. 8.Female subjects of childbearing potential must: Have a negative urine pregnancy test at screening and agree to use acceptable contraception during the study.
Exclusion criteria
Exclusion criteria: 1.Severe (Grade III) ankle sprain, complete ligament rupture, ankle dislocation, or suspected or confirmed fracture (based on clinical assessment or imaging, if performed) not considered amenable to treatment with topical NSAIDs alone. 2.Open skin lesion in the injured area. 3.Dermatological conditions, such as eczema or skin infections on the injured area. 4.Use of medication (other than the study drugs) for the treatment of complaints caused by the affected area. 5.Other inflammatory or painful conditions (e.g. headache, toothache). 6.Similar injury of the same area within the last 3 months. 7.Debilitating acute or chronic illness. 8.Use of long-acting NSAIDs, cyclooxygenase (COX)-2 inhibitors or tramadol in the previous 24 h; any other analgesics in the previous 6 h; use of any other topical products applied to the target site (Treatment by rest, ice, compression, or elevation prior to randomization is allowed). 9.Use of Systemic corticosteroid or immunosuppressive drugs in the previous 8 weeks. 10.Pregnant or lactating or planning to become pregnant during the study period. 11.Participants with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents. 12.History of Osteoarthritis, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia. 13.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease. 14.History of gastrointestinal bleeding or peptic ulcer disease. 15.Known allergy to aspirin or other Nonsteroidal Anti-Inflammatory Drug (NSAID), Known hypersensitivity or allergy to Diclofenac diethylamine (investigational product) and excipients of the formulation. 16.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past month prior to entry into the study. 17.Women of child-bearing age who are not surgically incapable of pregnancy and are unwilling to use an acceptable method of birth control. 18.Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s). 19.Unwillingness or inability to comply with the clinical trial procedures. 20.Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons. 21.Participants who are deemed to be legally incapacitated. 22.Participants who are legally detained in an official Institute.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Mean change in daily VAS pain on rest score at morning and at night from baseline to Day 7. Mean change in VAS of pain on movement of injured area from baseline to Day 3 and Baseline to Day 8. Proportion of participants with reduction in VAS of pain on movement of injured area from baseline to Day 3, Day 5 and Day 8. Mean change of normal function/activity of the injured area from baseline Day 1 to Day 3, Day 5 and Day 8.Proportion of participants with improvement in normal function/activity of the injured area on Day 3 compared to baseline Day 1, Day 5 compared to baseline Day 1 and Day 8 compared to baseline Day 1. Proportion of participants with improvement in passive joint mobility on Day 3 compared to baseline Day 1,Day 5 compared to baseline Day 1 and Day 8 compared to baseline Day 1Timepoint: From Baseline Day 1 to Day 3,Baseline Day 1 to Day 5,Baseline Day 1 to Day 8 | — |
Primary
| Measure | Time frame |
|---|---|
| To confirm the equivalence of clinical efficacy and tolerability of the generic Diclofenac diethylamine 2.32% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel (Reference) in patients with acute sprain of lateral ankle as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0-100) after seven days of treatmentTimepoint: From Baseline Day 1 to Day 5 (End of Treatment) | — |
Countries
India
Contacts
Public ContactT Vijaya Bhaskar
Invitro Research Solutions Pvt Ltd
Outcome results
None listed