Back PainPhase 3NCT01471899
Comparison Of Ketorolac Tromethamine Oral Drops 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.
Trial 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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to 30 Apr 2014
- 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 Analogic score 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
About this study
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
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.
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 analogic 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
10 drops each 8 hours for 4 days.
NaproxenDrug
2 tablets every 8 hours for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Naproxen | Active comparator | 2 tablets every 8 hours for 4 days. Receives: Drug: Naproxen |
| Ketorolac Tromethamine | Experimental | 10 drops 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 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;
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 completionDec 2013
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 78 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
- NCT01471899
- Sponsor's protocol ID
- CTRGEMS0611
- Status last verified
- Feb 2021
- First submitted
- 9 Nov 2011
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
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 Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
- ClinicalTrials.gov ID
- NCT01471899
- Acronym / sponsor ID
- CTRGEMS0611
- Conditions
- Back Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- 30 Apr 2014 (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 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.
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: Naproxen2 tablets every 8 hours for 4 days. |
| Ketorolac Tromethamine | Experimental | Drug: Ketorolac Tromethamine10 drops every 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 Analogic score 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 Tromethamine10 drops each 8 hours for 4 days. | Drug | Ketorolac Tromethamine |
| Naproxen2 tablets every 8 hours for 4 days | Drug | Naproxen |
Primary outcome
Efficacy of treatment in back pain relief based on Visual Analogic Score (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.
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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
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.
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.
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 Analogic Score (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?
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.