Back to resultsComparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Primary Purpose
Back Pain
Status
Completed
Phase
Phase 3
Locations
Brazil
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 Analog Scale 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
- IOT - Instituto de Ortopedia e Traumatologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Naproxen
Ketorolac Tromethamine
Arm Description
Every 8 hours for 4 days.
Every 8 hours for 4 days
Outcomes
Primary Outcome Measures
Efficacy of treatment in back pain relief based on Visual Analog Scale (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
NCT01471886
Brief Title
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Official Title
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine 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
October 2013 (Actual)
Study Completion Date
November 11, 2013 (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 of the clinical efficacy of two different drugs in the treatment of patients diagnosed with moderate to severe back pain.
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 analog 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
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Naproxen
Arm Type
Active Comparator
Arm Description
Every 8 hours for 4 days.
Arm Title
Ketorolac Tromethamine
Arm Type
Experimental
Arm Description
Every 8 hours for 4 days
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine
Intervention Description
Every 8 hours for 4 days.
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Every 8 hours for 4 days.
Primary Outcome Measure Information:
Title
Efficacy of treatment in back pain relief based on Visual Analog Scale (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 Analog Scale 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
Facility Information:
Facility Name
IOT - Instituto de Ortopedia e Traumatologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27382251
Citation
Plapler PG, Scheinberg MA, Ecclissato Cda C, Bocchi de Oliveira MF, Amazonas RB. Double-blind, randomized, double-dummy clinical trial comparing the efficacy of ketorolac trometamol and naproxen for acute low back pain. Drug Des Devel Ther. 2016 Jun 17;10:1987-93. doi: 10.2147/DDDT.S97756. eCollection 2016.
Results Reference
result
Learn more about this trial
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
We'll reach out to this number within 24 hrs