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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.