Ketoprofen Gel vs Placebo in Children With Ankle Sprain | NCT02491736

Studies
Ketoprofen Gel vs Placebo in Children With Ankle Sprain

NCT02491736

Sponsor

Akdeniz University

Status

Unknown status

Last Update Posted

Dec 3, 2015Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Ankle Sprain

Interventions

Ketoprofen
Placebo

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Jul 3, 2015

First Submission Date that Met QC Criteria

Jul 3, 2015

First Posted Date

Jul 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Ankle sprains may be associated with soft tissue injuries and fractures. Although diagnostic modalities are important, alleviation of pain is also a part of emergency department management. The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ketoprofen	Experimental	2.5% ketoprofen gel	Drug: Ketoprofen
Placebo	Placebo Comparator	Placebo gel	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ketoprofen	Drug	2.5% ketoprofen gel	ketoprofen	Fastjel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual Analogue Scale	Measurement of pain reduce at 30 minutes by visual analogue scale	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Adverse effects		30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with ankle sprain
Patients over 8 and lower than 18 years old

Exclusion Criteria:

Ankle sprain more than 24 hours
visual analogue scale score lower than 40mm
Allergy to the study drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aysel Özkan	Contact	00902582961758		karek@pau.edu.tr

Overall Officials

Name	Affiliation	Role
Mustafa Serinken, MD	Pamukkale University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pamukkale University	Recruiting	Denizli			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D016512	Ankle Injuries

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007660	Ketoprofen

Ancestor Terms

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided