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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by EMS
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01471899
First received: November 9, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Back Pain
Drug: Ketorolac Tromethamine
Drug: Naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS). [ Time Frame: 4 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: day 4 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Estimated Enrollment: 78
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471899

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

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

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01471899     History of Changes
Other Study ID Numbers: CTRGEMS0611
Study First Received: November 9, 2011
Last Updated: September 24, 2013
Health Authority: Brazil: National Health Surveillance Agency

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

ClinicalTrials.gov processed this record on September 18, 2014