Back to resultsComparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Primary Purpose
Back Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ketorolac Tromethamine
Naproxen
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Naproxen
Ketorolac Tromethamine
Arm Description
2 tablets every 8 hours for 4 days.
10 drops every 8 hours for 4 days
Outcomes
Primary Outcome Measures
Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).
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
Adverse events will be collected and followed in order to evaluate safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01471899
Brief Title
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain 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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
April 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naproxen
Arm Type
Active Comparator
Arm Description
2 tablets every 8 hours for 4 days.
Arm Title
Ketorolac Tromethamine
Arm Type
Experimental
Arm Description
10 drops every 8 hours for 4 days
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Intervention Description
10 drops each 8 hours for 4 days.
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
2 tablets every 8 hours for 4 days
Primary Outcome Measure Information:
Title
Efficacy of treatment in back pain relief based on Visual Analogic Score (VAS).
Description
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;
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pérola Plaper, MD
Organizational Affiliation
Instituto do Coracao
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
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