A Study To Evaluate The Efficacy And Safety of Aceclofenac Topical Ointment with Voveran Emulgel® (Diclofenac Sodium) For The Treatment of Acute Musculoskeletal Conditions

Phase 3

Not yet recruiting

• Conditions: Other soft tissue disorders related to use, overuse and pressure,

• Registration Number: CTRI/2020/10/028642
• Lead Sponsor: Panacea Biotec Pharma Ltd

Brief Summary

This is a  Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study  to evaluate the efficacy and safety of test product Aceclofenac topical ointment 1.5% w/w of Panacea Biotec Ltd. with comparator Voveran Emulgel® (Diclofenac Sodium1.0% w/w) gel of Novartis India Ltd. for the treatment of acute musculoskeletal conditions.Around 186 subjects will be randomized in this study (Including 20% drop outs), 93 subjects in each treatment arm & all subjects will have to apply 2 gm of study treatment topically to the affected area 2 times daily for 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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-10-24
• Study Start: 2020-10-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

• Subjects must meet all of the following criteria to be considered for enrollment in the study: 1.Male or non-pregnant female patients aged between 18-65 years with a clinical diagnosis of acute musculoskeletal conditions.
• 2.Patients with single site painful acute musculoskeletal conditions (tendinitis, bursitis, myalgia, low back-ache, sprains, pulled muscle, localized painful swelling 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.
• 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

• Subjects meeting any of the following criteria must be excluded from enrollment in the study: 1.
• 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 11.
• Elevated transaminases (≥ 3 times ULN) and hemoglobin < 9.0 g/dl at screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity at rest (Based on NRS)	Time frame: Baseline to day 8

Secondary Outcome Measures

Name	Time	Method
1.Overall clinical response based on 50% relief in patient pain.	2.Pain intensity at rest (Based on NRS).

Trial Locations

Locations (5)

All India Institute of Medical Sciences; 🇮🇳 West, DELHI, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Prakahar Hospital Pvt. Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

Rana Hospital Pvt Ltd; 🇮🇳 Gorakhpur, UTTAR PRADESH, India

S. N. Medical College; 🇮🇳 Agra, UTTAR PRADESH, India

All India Institute of Medical Sciences

🇮🇳West, DELHI, India

Dr Bhavuk Garg

Principal investigator

9899558021

drbhavukgarg@gmail.com