To determine the efficacy and safety of diclofenac topical solution in comparison with topical diclofenac gel in acute painful musculoskeletal conditions.

Phase 3

Completed

• Conditions: In acute painful musculoskeletal conditions

• Registration Number: CTRI/2010/091/003050
• Lead Sponsor: Troikaa Pharmaceuticals Ltd

Brief Summary

This study is a randomized, two arm, open label, active controlled, multicentric clinical study to evaluate the efficacy and safety of a topical solution of diclofenac (4.64% w/v) in comparison with diclofenac topical gel (1.16% w/w) in acute painful musculoskeletal conditions in total 250 patients at multiple sites in india. Patients are randomized to receive either topical diclofenac solution or diclofenac gel. The primary outcomes will be on set of analgesia,50% pain reduction at 7 days and Improvement in pain intensity as determined by VAS. The secondary out comes will be Need for rescue analgesia, Pain intensity at rest and passive movement,Degree of local signs (Swelling, Tenderness),Degree of functional impairment and Patients & Physicians global assessment.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-20
• Last Update Posted: 2014-04-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Male or females patients aged 18- 70 years.
• 2.Patients with acute low back ache (non- specific) or pain and inflammation following trauma to muscles/ tendons/ ligaments/ joints (due to strains, sprains, stress, soft tissue injuries or blunt sports injuries) for not more than 2 days 3.Patients with at least moderate pain of VAS ≥ 4.

Exclusion Criteria

• 1.Patients below 18 years or above 70 years of age.
• 2.Hypersensitivity to aspirin/ NSAID or any other component of the formulation 3.Any contraindication to diclofenac / NSAIDs 4.Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application 5.Concomitant skin disease at site of application 6.Use of another topical product at application site 7.Pregnant women and lactating mothers 8.Women of child bearing age not practicing or not willing to use contraceptive 9.
• Patients already on oral NSAIDs/ analgesics 10.
• Patients requiring hospitalization or other treatment for pain.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
50% pain reduction at 7 days.	End of the study visit

Secondary Outcome Measures

Name	Time	Method
Pain intensity at rest and passive movement	On day 3 and End of study visit
Need for rescue analgesia	During entire study period
Degree of functional impairment	End of study visit
Patients & Physicians global assessment	End of study visit
Degree of local signs (Swelling, Tenderness)	End of study visit

Trial Locations

Locations (5)

Bone & Joint Clinic; 🇮🇳 Madurai, TAMIL NADU, India

Panchal Pain Clinic; 🇮🇳 Surat, GUJARAT, India

Sancheti Institute for Orthopaedics and Rehabilitation; 🇮🇳 Pune, MAHARASHTRA, India

Satellite Orthopaedic Hospital And Research Centre Pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

Talesara Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Bone & Joint Clinic

🇮🇳Madurai, TAMIL NADU, India

Dr. S. Ramanathan

Principal investigator

91-9750626216

ramms_mdu@yahoo.co.in