Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextralgen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
o-Diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain;
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Carlos Gorios, Phd./MD | Sociedade Beneficente São Camilo | Principal Investigator |
| Paulo Guilherme Oliveira e Silva, Phd/MD | Hospital Santa Marcelina | Principal Investigator |
| Luciana Teixeira Pinto, Phd/MD | Instituto de Pesquisa Clínica e Medicina Avançada (IMA) | Principal Investigator |
| Sergio Raj Eis, Phd/MD | CEDOES | Principal Investigator |
| Jose Alexandre Mendonça, Phd/MD | Instituto de Pesquisa Clínica de Campinas (IPECC) | Principal Investigator |
| Sonia Maria Silva, Phd/MD | Faculdade de Medicina ABC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEDOES | Vitória | Espírito Santo | 29055-450 | Brazil | ||
| Sociedade Beneficente São Camilo |
Not provided
| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Meloxicam | Drug | 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. |
|
| Campinas |
| São Paulo |
| 05022-001 |
| Brazil |
| Instituto De Pesquisa Clínica De Campinas IPECC | Campinas | São Paulo | 13073-350 | Brazil |
| Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA | São Paulo | São Paulo | 05437-010 | Brazil |
| Hospital Santa Marcelina | São Paulo | São Paulo | 08270-070 | Brazil |
| Faculdade de Medicina ABC | São Paulo | São Paulo | 0960-650 | Brazil |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |