Topical Ketoprofen Versus Placebo in Patients With Ankle... | NCT02393846

Studies
Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

NCT02393846

Sponsor

Akdeniz University

Status

Completed

Last Update Posted

Jul 7, 2015Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Ankle Sprain

Interventions

Ketoprofen gel
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

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Mar 16, 2015

First Submission Date that Met QC Criteria

Mar 19, 2015

First Posted Date

Mar 20, 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

Jul 3, 2015

Last Update Posted Date

Jul 7, 2015Estimated

Name	Class
Pamukkale University	OTHER

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 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.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Ketoprofen gel	Drug	Topical ketoprofen as used in gel form.	ketoprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analogue scale	Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Adverse effects	Adverse effects occurred during the study is recorded to the study form.	30 minutes

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mustafa Serinken, MD	Pamukkale University	Study Chair

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D016512	Ankle Injuries
D004630	Emergencies

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries
D020969	Disease Attributes
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C117916	ketoprofen topical gel

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided