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

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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003050

Enrollment

250

Registered

2010-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- In acute painful musculoskeletal conditions

Interventions

Intervention1: Diclofenac topical solution: 4 times a day for 7 days Control Intervention1: Diclofenac Gel: 4 times a day for 7 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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

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

Design outcomes

Primary

Measure	Time frame
50% pain reduction at 7 days.Timepoint: End of the study visit;50% pain reduction at 7 days.Timepoint: End of the study visit;50% pain reduction at 7 days.Timepoint: End of the study visit	—

Secondary

Measure	Time frame
Degree of functional impairmentTimepoint: End of study visit;Degree of local signs (Swelling, Tenderness)Timepoint: End of study visit;Need for rescue analgesiaTimepoint: During entire study period;Pain intensity at rest and passive movementTimepoint: On day 3 and End of study visit;Patients & Physicians global assessmentTimepoint: End of study visit	—

Countries

India

Contacts

Public ContactDr Sanjay Maroo

GM-Medical Services Dept.

medicalservices@troikaapharma.com079-26856242

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026