Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
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double-blind, double-dummy, non-inferiority, prospective, parallel group, intent to treat trial.
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Experiment duration: 04 days.
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03 visits (days 0, 2 and 4).
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Efficacy will be evaluated for back pain relief based on visual analog scale.
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Adverse events evaluation.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Naproxen Every 8 hours for 4 days. |
Drug: Naproxen
Every 8 hours for 4 days.
|
Experimental: Ketorolac Tromethamine Every 8 hours for 4 days |
Drug: Ketorolac Tromethamine
Every 8 hours for 4 days.
|
Outcome Measures
Primary Outcome Measures
- Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS). [4 days]
The individual response rate to the relieve of pain is calculated by measuring VAS during the first and last visit. The response rate is calculated using the following formula: Response rate = (VASvi - VASvf) / VASvi Considering: VASvi: VAS in the first visit; VASvf: VAS at the last visit;
Secondary Outcome Measures
- Safety will be evaluated by the adverse events occurrences [day 4]
Adverse events will be collected and followed in order to evaluate safety and tolerability
Eligibility Criteria
Criteria
Inclusion Criteria:
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Consent of the patient or legal guardian.
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Men or women aged between 18 and 65.
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Diagnosis of acute low back pain with moderate to severe pain (Visual Analog Scale greater than 4 cm)
Exclusion Criteria:
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fracture confirmed by X-ray
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Diagnosis of infection, fever,
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Pregnancy, lactation;
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Diagnosis of fibromyalgia;
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Hypersensitivity to ketorolac tromethamine, any of the ingredients of the formula or other Nonsteroidal anti-inflammatory
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | IOT - Instituto de Ortopedia e Traumatologia | Sao Paulo | SP | Brazil | 05403-010 |
Sponsors and Collaborators
- EMS
Investigators
- Principal Investigator: PĂ©rola Plaper, MD, Instituto do Coracao
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CTREMS0611