Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain
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|ClinicalTrials.gov Identifier: NCT02393846|
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : July 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Ankle Sprain||Drug: Ketoprofen gel Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial|
|Study Start Date :||February 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.
Drug: Ketoprofen gel
Topical ketoprofen as used in gel form.
Other Name: Fastjel
Placebo Comparator: Placebo
Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.
Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.
Other Name: Placebo gel
- Visual analogue scale [ Time Frame: 30 minutes ]Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.
- Adverse effects [ Time Frame: 30 minutes ]Adverse effects occurred during the study is recorded to the study form.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393846
|Study Chair:||Mustafa Serinken, MD||Pamukkale University|