Back PainPhase 3NCT01471886
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
A Phase 3 study testing Ketorolac Tromethamine and Naproxen in people with Back Pain, run by EMS at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Ketorolac Tromethamine and Naproxen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2013to 11 Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IOT - Instituto de Ortopedia e Traumatologia
São Paulo, São Paulo, 05403-010
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Ketorolac Tromethamine, Naproxen
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac TromethamineDrug
Every 8 hours for 4 days.
NaproxenDrug
Every 8 hours for 4 days.
| Study group | Role | What they receive |
|---|---|---|
| Naproxen | Active comparator | Every 8 hours for 4 days. Receives: Drug: Naproxen |
| Ketorolac Tromethamine | Experimental | Every 8 hours for 4 days Receives: Drug: Ketorolac Tromethamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 4 days
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startMar 2013
- Primary completionOct 2013
- Study completion11 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pérola Plaper, MD, Principal investigator, Instituto do Coracao
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471886
- Sponsor's protocol ID
- CTREMS0611
- Status last verified
- Feb 2021
- First submitted
- 9 Nov 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27382251
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Double Dummy To Non-Inferiority Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
- ClinicalTrials.gov ID
- NCT01471886
- Acronym / sponsor ID
- CTREMS0611
- Conditions
- Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- 11 Nov 2013 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naproxen | Active comparator | Drug: NaproxenEvery 8 hours for 4 days. |
| Ketorolac Tromethamine | Experimental | Drug: Ketorolac TromethamineEvery 8 hours for 4 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketorolac TromethamineEvery 8 hours for 4 days. | Drug | Ketorolac Tromethamine |
| NaproxenEvery 8 hours for 4 days. | Drug | Naproxen |
Primary outcome
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: * VASvi: VAS in the first visit; * VASvf: VAS at the last visit;
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Results publication: PubMed 27382251Plapler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pérola Plaper, MD principal investigator
Instituto do Coracao
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac Tromethamine and Naproxen in people with Back Pain, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment in back pain relief based on Visual Analog Scale (VAS). (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01471886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.