To determine the efficacy and safety of topical diclofenac solution in comparison with topical diclofenac gel in acute painful musculoskeletal conditions.
- Conditions
- Health Condition 1: null- Acute Painful Musculoskeletal Conditions
- Registration Number
- CTRI/2009/091/000799
- Lead Sponsor
- Troikaa Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 250
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.