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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 December 2015 |
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Main ID: |
NCT02491736 |
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Date of registration:
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03/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ketoprofen Gel vs Placebo in Children With Ankle Sprain
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Scientific title:
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Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial |
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Date of first enrolment:
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June 2015 |
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Target sample size:
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100 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02491736 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Aysel Özkan |
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Address:
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Telephone:
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00902582961758 |
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Email:
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karek@pau.edu.tr |
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Affiliation:
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Name:
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Aysel Özkan |
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Address:
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Telephone:
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00902582961758 |
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Email:
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karek@pau.edu.tr |
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Affiliation:
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Name:
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Mustafa Serinken, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pamukkale University |
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Key inclusion & exclusion criteria
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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
Age minimum:
8 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankle Sprain
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Intervention(s)
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Drug: Ketoprofen
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Other: Placebo
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Primary Outcome(s)
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Visual Analogue Scale
[Time Frame: 30 minutes]
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Secondary Outcome(s)
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Adverse effects
[Time Frame: 30 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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