To determine the efficacy and safety of topical diclofenac 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 (2.32% 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/2009/091/000799

Enrollment

250

Registered

2009-10-05

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- Acute Painful Musculoskeletal Conditions

Interventions

Intervention1: Topical Diclofenac solution (Diclofenac diethyl ammonium 2.32% w/v): To be applied at the site of pain 4 times a day Control Intervention1: Topical diclofenac gel (Diclofenac diethyl am

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 greater than or equals to 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.Unwilling patients. 10.Patients already on oral NSAIDs/ analgesics. 11.Patients requiring hospitalization or other treatment for pain.

Design outcomes

Primary

Measure	Time frame
Improvement in pain intensity from baseline, as determined by VAS (0- 10).Timepoint: At the end of day 3 and day 7;Improvement in pain intensity from baseline, as determined by VAS (0- 10).Timepoint: At the end of day 3 and day 7;Improvement in pain intensity from baseline, as determined by VAS (0- 10).Timepoint: At the end of day 3 and day 7	—

Secondary

Measure	Time frame
Degree of functional impairmentTimepoint: On 1st, 3rd and 7th day.;Degree of local signs (swelling, tenderness)Timepoint: On 1st, 3rd and 7th day.;Global assessment by Physician and patientsTimepoint: At the end of study (7th day);Need for rescue analgesicTimepoint: On 3rd and 7th day.;No. of adverse event, No. of patients with adverse eventsTimepoint: On 3rd and 7th day.;Pain intensity at rest and on passive movementTimepoint: On 1st, 3rd and 7th day.	—

Measure

Time frame

Degree of functional impairmentTimepoint: On 1st, 3rd and 7th day.;Degree of local signs (swelling, tenderness)Timepoint: On 1st, 3rd and 7th day.;Global assessment by Physician and patientsTimepoint: At the end of study (7th day);Need for rescue analgesicTimepoint: On 3rd and 7th day.;No. of adverse event, No. of patients with adverse eventsTimepoint: On 3rd and 7th day.;Pain intensity at rest and on passive movementTimepoint: On 1st, 3rd and 7th day.

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Countries

India

Contacts

Public ContactDr Vijaya Jaiswal

Troikaa Pharmaceuticals Limited

vijayajaiswal@troikaapharma.com07926856242

Outcome results

None listed

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