Health Condition 1: M958- Other specified acquired deformities of musculoskeletal system
Conditions
Interventions
Intervention1: Diclofenac diethylamine gel, 2.32%: Investigational product will be applied (2 grams per application) to the affected area twice daily (morning and evening) for 5 days.
Control Interven
Sponsors
TARO Pharmaceuticals
JSS Medical Research Asia Pacific Private limited Faridabad Haryana India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy male or non-pregnant female aged = 18 and = 65 years with a clinical diagnosis of acute sprain of lateral ankle. 2. Subjects must have provided IRB-approved written informed consent/assent. 3. Subjects must be willing to refrain from using all therapies for treatment of pain during the treatment period, other than the investigational product. 4. Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
Exclusion criteria
Exclusion criteria: 1.Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. 2. Subjects with a history of hypersensitivity or allergy to diclofenac, or any other NSAIDs such as ibuprofen, ASA or naproxen, and/or any of the study medication ingredients. 3. Any physical impairment that would influence the study’s efficacy evaluations, such as: peripheral or central neurological disease, significant back pain, symptomatic osteoarthritis of the hips, knees or feet, or any painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart). 4. Subjects who have unstable medical disorders that are clinically significant or have life-threatening diseases, or other medical condition that, in the Investigator’s opinion, would place the study Subject at undue risk by participation or could jeopardize the integrity of the study evaluations. 5. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or use drugs of abuse (including, but not limited to, cannabinoids, cocaine and barbiturates). 6. Subjects who have participated in an investigational drug study (i.e., Subjects have been treated with an investigational drug) within 30 days prior to baseline. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion. 7. Subjects who have been previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Day 5 in Pain on Movement (POM) as assessed by a 100 mm VAS scaleTimepoint: At each visit, beginning at Visit 1, an Investigator will perform a manipulation of the ankle (i.e., movement) and the pain assessment will be done by the subject using a 100 mm VAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Neeraj Prasad
JSS Medical Research Asia Pacific Pvt. Ltd.
Outcome results
None listed