Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
NCT ID: NCT01471899
Last Updated: 2021-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
78 participants
INTERVENTIONAL
2013-03-31
2014-04-30
Brief Summary
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Detailed Description
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* Experiment duration: 04 days.
* 03 visits (days 0, 2 and 4).
* Efficacy will be evaluated for back pain relief based on visual analogic scale.
* Adverse events evaluation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Naproxen
2 tablets every 8 hours for 4 days.
Naproxen
2 tablets every 8 hours for 4 days
Ketorolac Tromethamine
10 drops every 8 hours for 4 days
Ketorolac Tromethamine
10 drops each 8 hours for 4 days.
Interventions
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Ketorolac Tromethamine
10 drops each 8 hours for 4 days.
Naproxen
2 tablets every 8 hours for 4 days
Eligibility Criteria
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Inclusion Criteria
* Men or women aged between 18 and 65.
* Diagnosis of acute low back pain with moderate to severe pain (Visual Analogic score greater than 4 cm)
Exclusion Criteria
* Diagnosis of infection, fever,
* Pregnancy, lactation;
* Diagnosis of fibromyalgia;
* Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory
18 Years
65 Years
ALL
No
Sponsors
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EMS
INDUSTRY
Responsible Party
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Principal Investigators
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Pérola Plaper, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto do Coracao
Other Identifiers
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CTRGEMS0611
Identifier Type: -
Identifier Source: org_study_id
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