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

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ClinicalTrials.gov Identifier: NCT01471899
Recruitment Status : Unknown
Verified September 2013 by EMS.
Recruitment status was:  Not yet recruiting
First Posted : November 16, 2011
Last Update Posted : September 25, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Back Pain Drug: Ketorolac Tromethamine Drug: Naproxen Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Study Start Date : October 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Naproxen
2 tablets every 8 hours for 4 days.
Drug: Naproxen
2 tablets every 8 hours for 4 days
Experimental: Ketorolac Tromethamine
10 drops every 8 hours for 4 days
Drug: Ketorolac Tromethamine
10 drops each 8 hours for 4 days.

Outcome Measures

Primary Outcome Measures :
  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


    • VASvi: VAS in the first visit;
    • VASvf: VAS at the last visit;

Secondary Outcome Measures :
  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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01471899

Contact: Felipe Pinho, MD +551938879359 felipe.pinho@ems.com.br

Sponsors and Collaborators
Principal Investigator: Pérola Plaper, MD Instituto do Coracao
More Information

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01471899     History of Changes
Other Study ID Numbers: CTRGEMS0611
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants