CTRI/2022/03/041507Not yet recruitingPhase 3
A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Combination Topical Ointment 1.5% w/w with HIFENAC GEL® 1.5% w/w For The Management of Acute Pain in Musculoskeletal Conditions
Panacea Biotec Pharma Ltd5 sites in 1 country186 target enrollmentStarted: March 30, 2022Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 186
- Locations
- 5
- Primary Endpoint
- The primary efficacy end point pertaining to Pain intensity at rest (Based on NRS) will be assessed by comparing Pain intensity (at rest) in both the arms.
Study Overview
Brief Summary
Aceclofenacis frequently prescribed by oral route for the management of acute pain associated with musculoskeletal conditions. For the ease of application, enhanced stability,decreased side effects, enhanced patient compliance, and the ease ofdiscontinuation on desire, there have been a lot of efforts to deliver AC bytopical route.
This comparative clinical study to evaluate the efficacy and safety of Aceclofenac combination topical ointment, 1.5% w/w withHIFENAC GEL® ,1.5% w/w, for the Management of Acute Pain inMusculoskeletal Conditions. Total 186 subjects will berandomized in this study 93 subjects in eachtreatment arm. All subjects will haveto apply study treatment topically to the affected area 2 times dailyfor 8 days.
Efficacy of the study drug will be measured by in terms of pain intensity, overall clinical response and need for the rescue medications and safety by reported adverse events during the study.
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
- •1.Male or non-pregnant female patients aged between 18-65 years with a clinical diagnosis of acute pain in musculoskeletal conditions.
- •2.Patients with single site painful acute musculoskeletal conditions (tendinitis, bursitis, myalgia, low back-ache, sprains, pulled muscle, soft tissue injury etc.) sustained within 48 hours of screening (not requiring surgical treatment).
- •3.Patients with at least moderate pain at rest of Numeric rating Scale (NRS) greater or equal to
- •4.Patient is able to provide written informed consent prior to study.
- •5.Willingness to comply with the study schedule and procedures.
- •6.If female, patient must be either postmenopausal for at least one year prior to randomization, surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or practicing the following methods of birth control: a) Oral Contraceptives or Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or b) Double Barrier methods containing or used in conjunction with a spermicidal agent, or c) Contraceptive Patches/ Implants, or d) Abstinence: Subjects who will be practicing abstinence will agree to have an acceptable method of birth control if the subject becomes sexually active during the course of her study participation.
- •All male subjects must agree to use accepted methods of birth control with their partners during the study.
- •Abstinence is an acceptable method of birth control.
- •Any of the following methods of birth control are acceptable: oral contraceptives, contraceptive patches/implants (e.g., Norplant®), Depo-Provera®, double barrier methods (e.g., condom and spermicide) or IUD.
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 screening.
- •Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
- •Known hypersensitivity to Aceclofenac or any other ingredient of product or to rescue medication acetaminophen (Paracetamol).
- •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 90 days.
- •History of regular fever, headaches which warrants frequent use of acetaminophen (Paracetamol) or NSAIDS
- •Elevated transaminases (≥ 3 times ULN) and hemoglobin < 9.0 g/dl at screening.
Outcomes
Primary Outcomes
The primary efficacy end point pertaining to Pain intensity at rest (Based on NRS) will be assessed by comparing Pain intensity (at rest) in both the arms.
Time Frame: [Time frame: Baseline (day o) to day 8]
Secondary Outcomes
- 1.Overall clinical response based on 50% relief in patient pain.(2.Pain intensity at rest (Based on NRS).)
Investigators
Study Sites (5)
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