Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

NCT ID: NCT02393846

Last Updated: 2015-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-06-30

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.

Conditions

Ankle Sprain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ketoprofen

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

Group Type: EXPERIMENTAL

Ketoprofen gel

Intervention Type: DRUG

Topical ketoprofen as used in gel form.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Ketoprofen gel

Topical ketoprofen as used in gel form.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Fastjel; Placebo gel

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: collaborator

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Cenker Eken

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa Serinken, MD

Role: STUDY_CHAIR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

PAU2015/05

Identifier Type: -

Identifier Source: org_study_id