- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01471886
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
February 23, 2021 updated by: EMS
Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / 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 analog scale.
- Adverse events evaluation.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
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Sao Paulo, SP, Brazil, 05403-010
- IOT - Instituto de Ortopedia e Traumatologia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Naproxen
Every 8 hours for 4 days.
|
Every 8 hours for 4 days.
|
EXPERIMENTAL: Ketorolac Tromethamine
Every 8 hours for 4 days
|
Every 8 hours for 4 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of treatment in back pain relief based on Visual Analog Scale (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:
|
4 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
day 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pérola Plaper, MD, Instituto do Coracao
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2013
Primary Completion (ACTUAL)
October 1, 2013
Study Completion (ACTUAL)
November 11, 2013
Study Registration Dates
First Submitted
November 9, 2011
First Submitted That Met QC Criteria
November 15, 2011
First Posted (ESTIMATE)
November 16, 2011
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 23, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Back Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gout Suppressants
- Ketorolac
- Naproxen
- Ketorolac Tromethamine
Other Study ID Numbers
- CTREMS0611
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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