A Study To Evaluate Efficacy And Safety of Aceclofenac Combination Topical Ointment in Comparison to Reference Product HIFENAC GEL® in Management of Acute Pain in Musculoskeletal Conditions.

Phase 3

• Conditions: Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure

• Registration Number: CTRI/2022/03/041507
• Lead Sponsor: Panacea Biotec Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

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.

7. 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

1. Patients with any condition which in opinion of the investigator

makes the patient unsuitable for inclusion.

2. Patients with painful muscle spasms associated with

musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.

3. Patient with history of osteoarthritis / rheumatoid arthritis.

4. Patients with skin wounds, open injuries or other conditions of

broken skin at the site of proposed application.

5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study screening.

6. Patients with history of severe cardiac, hepatic, gastrointestinal,

renal, pulmonary and skin diseases.

7. Known hypersensitivity to Aceclofenac or any other

ingredient of product or to rescue medication acetaminophen (Paracetamol).

8. 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.

9. Participation in any other clinical trial during last 90 days.

10. 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