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Trial record 50 of 346 for:    sprains and strains

Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain

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ClinicalTrials.gov Identifier: NCT02393846
Recruitment Status : Completed
First Posted : March 20, 2015
Last Update Posted : July 7, 2015
Sponsor:
Collaborator:
Pamukkale University
Information provided by (Responsible Party):
Cenker Eken, Akdeniz University

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.

Condition or disease Intervention/treatment Phase
Ankle Sprain Drug: Ketoprofen gel Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Topical Dexketoprofen Versus Placebo in Patients Presented With Ankle Sprain to the Emergency Department: A Randomised Placebo Controlled Trial
Study Start Date : February 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen

Arm Intervention/treatment
Experimental: ketoprofen
Topical ketoprofen (gel) is the experimental drug that is applied to the ankle in a dose of 2 gr.
Drug: Ketoprofen gel
Topical ketoprofen as used in gel form.
Other Name: Fastjel

Placebo Comparator: Placebo
Topical placebo (gel) is identical in colour, form and smell with the ketoprofen gel.
Drug: Placebo
Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.
Other Name: Placebo gel




Primary Outcome Measures :
  1. Visual analogue scale [ Time Frame: 30 minutes ]
    Pain intensity is measured by visual analogue scale at baseline, 15 and 30 minutes after the administration.


Secondary Outcome Measures :
  1. Adverse effects [ Time Frame: 30 minutes ]
    Adverse effects occurred during the study is recorded to the study form.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393846


Locations
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Turkey
Pamukkale University
Denizli, Turkey
Sponsors and Collaborators
Akdeniz University
Pamukkale University
Investigators
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Study Chair: Mustafa Serinken, MD Pamukkale University

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Responsible Party: Cenker Eken, Associate Professor, Akdeniz University
ClinicalTrials.gov Identifier: NCT02393846     History of Changes
Other Study ID Numbers: PAU2015/05
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Cenker Eken, Akdeniz University:
ankle sprain
topical ketoprofen
non-steroidal anti-inflammatory drug
emergency department

Additional relevant MeSH terms:
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Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action