Lumbar Sciatic PainPhase 3DextraNCT01147289
Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain
A Phase 3 study testing Dextralgen and Meloxicam in people with Lumbar Sciatic Pain, run by Eurofarma Laboratorios S.A. at 6 sites in Brazil.
Trial summary
A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Sciatic Pain
- What is being tested?
- Dextralgen and Meloxicam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 6 sitesBrazil
- Study dates
- Feb 2011to Apr 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign the study informed consent form;
- To be diagnosed with moderate to severe lumbar sciatic pain (defined as limiting the work activities or the ordinary tasks performance or at the investigator's discretion) within the last 3 days;
- Aged 18 to 75 years old;
- To be able to meet the study procedures
Who cannot join
- o-Diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain;
- Patients with one of the following conditions, as per the investigator's criteria:
- Severe renal failure under hemodialysis, severe liver failure, uncontrolled severe heart failure;
- Severe injuries on gastrointestinal tract;
- Other severe comorbidities;
- Patients taking acetylsalicylic acid or any anti-clotting;
- Female patients who are pregnant, lactating, willing to get pregnant or not willing to use an appropriate contraceptive method during the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Brazil6 sites
Sociedade Beneficente São Camilo
Campinas, São Paulo, 05022-001
Instituto De Pesquisa Clínica De Campinas IPECC
Campinas, São Paulo, 13073-350
Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA
São Paulo, São Paulo, 05437-010
Hospital Santa Marcelina
São Paulo, São Paulo, 08270-070
Faculdade de Medicina ABC
São Paulo, São Paulo, 0960-650
CEDOES
Vitória, Espírito Santo, 29055-450
About this study
Official title: A Phase III, Randomized, Multicenter, Open Label Clinical Trial: Efficacy and Safety of the Injectable Association of Dexamethasone, Dipyrone, and Hydrocobalamin in Lumbar Sciatic Pain
A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).
- Conditions
- Lumbar Sciatic Pain
- Being tested
- Dextralgen, Meloxicam
- Keywords
- lumbar sciatic pain, moderate to severe lumbar sciatic pain within the last three days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextralgenDrug
Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
MeloxicamDrug
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
| Study group | Role | What they receive |
|---|---|---|
| dexalgen | Experimental | Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose for 3 days, at least Receives: Drug: Dextralgen |
| Meloxicam | Active comparator | Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose for at least 3 days. Receives: Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy
The efficacy analysis will be at the per protocol population, with the VAS measure after three treatment dosages. The VAS scale consists on a straight line of 100 mm in which the patient marks, at any point through the straight line, the point he/she considers to describe the pain level he/she feels. After the patient marks the straight line, classifying his/her pain, it is measured with a millimeter-graded standard rule, the distance between the mark and the extremity "No pain" at the scale.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Sciatic PainStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Gorios, Phd./MD, Principal investigator, Sociedade Beneficente São CamiloPaulo Guilherme Oliveira e Silva, Phd/MD, Principal investigator, Hospital Santa MarcelinaLuciana Teixeira Pinto, Phd/MD, Principal investigator, Instituto de Pesquisa Clínica e Medicina Avançada (IMA)Sergio Raj Eis, Phd/MD, Principal investigator, CEDOESJose Alexandre Mendonça, Phd/MD, Principal investigator, Instituto de Pesquisa Clínica de Campinas (IPECC)Sonia Maria Silva, Phd/MD, Principal investigator, Faculdade de Medicina ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147289
- Sponsor's protocol ID
- EF 102
- Acronym
- Dextra
- Status last verified
- May 2012
- First submitted
- 16 Jun 2010
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multicenter, Open Label Clinical Trial: Efficacy and Safety of the Injectable Association of Dexamethasone, Dipyrone, and Hydrocobalamin in Lumbar Sciatic Pain
- ClinicalTrials.gov ID
- NCT01147289
- Acronym / sponsor ID
- Dextra / EF 102
- Conditions
- Lumbar Sciatic Pain
- Keywords
- lumbar sciatic pain, moderate to severe lumbar sciatic pain within the last three days
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Jun 2010 (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.
A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexalgen | Experimental | Drug: DextralgenDexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose for 3 days, at least |
| Meloxicam | Active comparator | Drug: MeloxicamMeloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose for at least 3 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sign the study informed consent form;
- To be diagnosed with moderate to severe lumbar sciatic pain (defined as limiting the work activities or the ordinary tasks performance or at the investigator's discretion) within the last 3 days;
- Aged 18 to 75 years old;
- To be able to meet the study procedures
Key exclusion criteria (7 listed)
- o-Diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain;
- Patients with one of the following conditions, as per the investigator's criteria:
- Severe renal failure under hemodialysis, severe liver failure, uncontrolled severe heart failure;
- Severe injuries on gastrointestinal tract;
- Other severe comorbidities;
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 |
|---|---|---|
| DextralgenDexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least. | Drug | dexalgen |
| MeloxicamMeloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least. | Drug | Meloxicam |
Primary outcome
efficacy
Time frame: 6 months
The efficacy analysis will be at the per protocol population, with the VAS measure after three treatment dosages. The VAS scale consists on a straight line of 100 mm in which the patient marks, at any point through the straight line, the point he/she considers to describe the pain level he/she feels. After the patient marks the straight line, classifying his/her pain, it is measured with a millimeter-graded standard rule, the distance between the mark and the extremity "No pain" at the scale.
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 28 Mar 2025.
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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.
Carlos Gorios, Phd./MD principal investigator
Sociedade Beneficente São Camilo
Paulo Guilherme Oliveira e Silva, Phd/MD principal investigator
Hospital Santa Marcelina
Luciana Teixeira Pinto, Phd/MD principal investigator
Instituto de Pesquisa Clínica e Medicina Avançada (IMA)
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextralgen and Meloxicam in people with Lumbar Sciatic Pain, run by Eurofarma Laboratorios S.A. at 6 sites 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 4 inclusion and 7 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 (time frame: 6 months). 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 28 Mar 2025.