To evaluate Safety and Efficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate and Menthol In Painful Musculoskeletal Conditions.

Phase 4

Completed

• Conditions: Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,

• Registration Number: CTRI/2013/06/003751
• Lead Sponsor: Inventia Healthcare Private Limited

Brief Summary

A Multi-center, Prospective, Open-label,Randomized, Active-Controlled, Parallel-Group Clinical Study of Safety andEfficacy of Diclofenac Diethylamine Gel with Capsaicin, Methyl Salicylate andMenthol In Painful Musculoskeletal Conditions. Eligible patients will be randomised based on 1:1 ratio of test and reference product 2-4 fingertip units (providing 20-40 mg ofdiclofenac) should be applied to the affected area three to four times daily for 7 Days. During treatment period also assess the VAS and Physician’s GlobalAssessment Scale. Safety evaluated based on measurements of laboratory investigations ofSGOT, SGPT, serum creatinine and urea at the end of the study visit andreporting of any adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-15
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1.Male or female patients aged 18 – 65 years (both inclusive).
• 2.Patients with mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures like sprains, strains, as well as tendinitis, bursitis, neck & shoulder pain, sciatica, muscle stiffness, joint pain and lumbago.
• 3.Patients with at least moderate pain of Visual Analogue Scale (VAS)greater or equal to 3.
• 4.Patient is able to provide written informed consent prior to study.
• 5.Willingness to comply with the study schedule and procedures.

Exclusion Criteria

• 1.Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
• 2.Patients with known history of severe osteoarthritis and rheumatoid arthritis.
• 3.Patients with active or recent history of inflammatory diseases of the gastrointestinal tract such as peptic ulcer, gastritis, regional enteritis, or ulcerative colitis.
• 4.History of aspirin-sensitive asthma, adverse reaction to oral nonsteroidal anti-inflammatory drug (NSAID), bleeding diathesis, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease or in the setting of coronary artery bypass graft surgery (CABGS).
• 5.Patients with uncontrolled hypertension(Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
• 6.Patients with open wounds infected skin or other conditions of broken skin, skin affected by infection, inflammations at the site of proposed application.
• 7.Patients underlying dermatitis or dermatosis associated with the injury.
• 8.Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study, or any other topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetics.
• 9.Known hypersensitivity to aspirin, diclofenac diethylamine or any other ingredient of product.
• 10.Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the patient at risk by participating in the study.
• 11.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.
• 12.Participation in any other clinical trial during last 30 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Overall clinical response based on 50% relief in patient pain.	7 Days
2.Pain intensity (Based on VAS).	7 Days

Secondary Outcome Measures

Name	Time	Method
1.Physician’s Global Assessment Scale.	2.Need for rescue medication (acetaminophen).

Trial Locations

Locations (5)

Divyadarshan Orthopedic Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dr. Shukla’s Hospital; 🇮🇳 Surat, GUJARAT, India

Poojan Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Shree Giriraj Multispeciality Hospital; 🇮🇳 Rajkot, GUJARAT, India

Shubh Hospital; 🇮🇳 Vadodara, GUJARAT, India

Divyadarshan Orthopedic Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Darshan Shah

Principal investigator

09825018004

divyadarshan22@yahoo.com