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Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Primary Purpose

Ankle Sprain

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Ketoprofen gel

Placebo

About this trial

This is an interventional treatment trial for Ankle Sprain focused on measuring ankle sprain, topical ketoprofen, non-steroidal anti-inflammatory drug, emergency department

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ketoprofen

Placebo

Arm Description

Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.

Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.

Outcomes

Primary Outcome Measures

Visual analogue scale

Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.

Secondary Outcome Measures

Adverse effects

Adverse effects occurred during the study is recorded to the study form.

Full Information

NCT ID

NCT02393846

First Posted

March 16, 2015

Last Updated

July 3, 2015

Sponsor

Akdeniz University

Collaborators

Pamukkale University

1. Study Identification

Unique Protocol Identification Number

NCT02393846

Brief Title

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

Official Title

Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Akdeniz University

Collaborators

Pamukkale University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankle Sprain

Keywords

ankle sprain, topical ketoprofen, non-steroidal anti-inflammatory drug, emergency department

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ketoprofen

Arm Type

Experimental

Arm Description

Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.

Intervention Type

Drug

Intervention Name(s)

Ketoprofen gel

Other Intervention Name(s)

Fastjel

Intervention Description

Topical ketoprofen as used in gel form.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo gel

Intervention Description

Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.

Primary Outcome Measure Information:

Title

Visual analogue scale

Description

Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Adverse effects

Description

Adverse effects occurred during the study is recorded to the study form.

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mustafa Serinken, MD

Organizational Affiliation

Pamukkale University

Official's Role

Study Chair

Facility Information:

Facility Name

Pamukkale University

City

Denizli

Country

Turkey

12. IPD Sharing Statement

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Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

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