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Completed

NCT Number: NCT01471899

Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

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.

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Key information

Conditions

Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Tromethamine

Drug

10 drops each 8 hours for 4 days.

Naproxen

Drug

2 tablets every 8 hours for 4 days

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 16, 2011
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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