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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02393846
Other study ID # PAU2015/05
Secondary ID
Status Completed
Phase Phase 4
First received March 16, 2015
Last updated July 3, 2015
Start date February 2015
Est. completion date June 2015

Study information

Verified date July 2015
Source Akdeniz University
Contact n/a
Is FDA regulated No
Health authority Turkey: Drug and Medical Device Institution
Study type Interventional

Clinical Trial Summary

The aim of this study is to analyse the effect of ketoprofen gel in patients presented with ankle sprain to the emergency department.


Description:

Patients, 18-65 years old, presented with ankle sprain are enrolled into the study. Pain over 24 hours, pain intensity lower than 40 mm, allergy to the study drug, drug alcohol abuse and pregnancy or breastfeeding are the exclusion criteria. The study interventions are 2 gr of 2.5% ketoprofen gel versus placebo applied to the sprain area. The study drugs are identical in colour, form and smelling. After an eligible patient presented to the ED, the drug number from an opaque bag is determined by a nurse and then another nurse applies the study drug to the patient. Physicians, nurses and patients are blinded to the study drug. Pain intensity of patients is measured by visual analogue scale at baseline, 15th and 30th minutes after the administration.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketoprofen gel
Topical ketoprofen as used in gel form.
Placebo
Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.

Locations

Country Name City State
Turkey Pamukkale University Denizli

Sponsors (2)

Lead Sponsor Collaborator
Akdeniz University Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue scale Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration. 30 minutes No
Secondary Adverse effects Adverse effects occurred during the study is recorded to the study form. 30 minutes Yes
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