NCT02393846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 7, 2015

Status Verified

July 1, 2015

Enrollment Period

4 months

First QC Date

March 16, 2015

Last Update Submit

July 3, 2015

Conditions

Ankle Sprain

Keywords

ankle spraintopical ketoprofennon-steroidal anti-inflammatory drugemergency department

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

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

    30 minutes

Secondary Outcomes (1)

  • Adverse effects

    30 minutes

Study Arms (2)

ketoprofen

EXPERIMENTAL

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

Drug: Ketoprofen gel

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Ketoprofen gelDRUG

Topical ketoprofen as used in gel form.

Also known as: Fastjel
ketoprofen
PlaceboDRUG

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

Also known as: Placebo gel
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient presented with ankle sprain to the emergency department.
  • Patients between 18-65 years old.

You may not qualify if:

  • Pain over 24 hours,
  • Pain intensity lower than 40 mm,
  • allergy to the study drug,
  • drug alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle InjuriesEmergencies

Interventions

ketoprofen topical gel

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mustafa Serinken, MD

    Pamukkale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 16, 2015

First Posted

March 20, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 7, 2015

Record last verified: 2015-07

Locations

TU(1)