Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02393846
• Date of registration: 16/03/2015
• Prospective Registration: No
• Primary sponsor: Akdeniz University
• Public title: Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain
• Scientific title: Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial
• Date of first enrolment: February 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02393846
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Mustafa Serinken, MD
• Affiliation: Pamukkale University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient presented with ankle sprain to the emergency department.

- Patients between 18-65 years old.

Exclusion Criteria:

- Pain over 24 hours,

- Pain intensity lower than 40 mm,

- allergy to the study drug,

- drug alcohol abuse

- pregnancy or breastfeeding are the exclusion criteria.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Ankle Sprain

Intervention(s)

Drug: Placebo

Drug: Ketoprofen gel

Primary Outcome(s)

Visual analogue scale [Time Frame: 30 minutes]

Secondary Outcome(s)

Adverse effects [Time Frame: 30 minutes]

Secondary ID(s)

PAU2015/05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pamukkale University