A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Topical Gel 5% w/w Compare with HIFENAC GEL® 1.5% w/w For The Treatment of Sprain and Muscle Pain
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- 1. Overall clinical response based on 50% relief in patient pain.
Study Overview
Brief Summary
This is a Phase III, Multicenter, Randomized, Open Label, Parallel Group,Comparative Clinical Study to evaluatethe efficacy and safety of Aceclofenac Topical Gel 5% w/w comparewith HIFENAC GEL® 1.5% w/w for thetreatment of Sprain and Muscle Pain. Eligible patients randomisedbased on 1:1 ratio will be applied test orreference product topically gently to cover the affected skin area twice dailyfor 7 days. If efficacy is not confirmed on day 7, treatment will be extendedfor non-responders for up to 14 days. Overall clinical responsebased on 50 % relief in sign and symptoms, pain intensity based on VAS andPhysician’s Global Assessment Scale will be evaluated at the end of study visitand at follow-up visit as compared to baseline. Safetywill be evaluated based on measurements of laboratory investigations ofSGOT, SGPT, Serum Creatinine and Urea at the end of thestudy visit and by reporting of any adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex between 18-65 years of age.
- •Patients with painful sprain and/or muscle pain.
- •Patients with at least moderate pain of Visual Analogue Scale (VAS) greater or equal to
- •Patient is able to provide written informed consent prior to study.
- •Willingness to comply with the study schedule and procedures.
Exclusion Criteria
- •Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.
- •Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
- •Patient with history of osteoarthritis / rheumatoid arthritis.
- •Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
- •Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study.
- •Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
- •Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Known hypersensitivity to aspirin, aceclofenac or any other ingredient of product.
- •Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
- •Participation in any other clinical trial during last 30 days.
Outcomes
Primary Outcomes
1. Overall clinical response based on 50% relief in patient pain.
Time Frame: 7-14 days
2. Pain intensity (Based on VAS).
Time Frame: 7-14 days
Secondary Outcomes
- 1. Physician’s Global Assessment Scale.(2. Need for rescue medication.)