Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Overview
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain treatment.
Full Title of Study: “Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: December 2013
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 pain relief based on visual analogic scale. – Adverse events evaluation.
Interventions
- Drug: Ketorolac Tromethamine
- 10 drops each 8 hours for 4 days.
- Drug: Naproxen
- 2 tablets every 8 hours for 4 days
Arms, Groups and Cohorts
- Active Comparator: Naproxen
- 2 tablets every 8 hours for 4 days.
- Experimental: Ketorolac Tromethamine
- 10 drops every 8 hours for 4 days
Clinical Trial Outcome Measures
Primary Measures
- Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).
- Time Frame: 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 Measures
- Safety will be evaluated by the adverse events occurrences
- Time Frame: day 4
- Adverse events will be collected and followed in order to evaluate safety and tolerability
Participating in This Clinical Trial
Inclusion Criteria
- 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 Analogic score greater than 4 cm) Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- EMS
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Pérola Plaper, MD, Principal Investigator, Instituto do Coracao
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