Status:
COMPLETED
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Lead Sponsor:
EMS
Conditions:
Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.
Detailed Description
* double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial. * Experiment duration: 04 days. * 03 visits (days 0, 2 and 4). * Efficacy will be evaluated for back ...
Eligibility Criteria
Inclusion
- Consent of the patient or legal guardian.
- Men or women aged between 18 and 65.
- Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale greater than 4 cm)
Exclusion
- fracture confirmed by X-ray
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2013
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01471886
Start Date
March 1 2013
End Date
November 11 2013
Last Update
February 24 2021
Active Locations (1)
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1
IOT - Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, Brazil, 05403-010