Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain (Dextra)
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:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- efficacy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||February 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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
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.
Active Comparator: Meloxicam
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose for at least 3 days.
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.
|Vitoria, Espirito Santo, Brazil, 29055-450|
|Sociedade Beneficente São Camilo|
|Campinas, São Paulo, Brazil, 05022-001|
|Instituto De Pesquisa Clínica De Campinas IPECC|
|Campinas, São Paulo, Brazil, 13073-350|
|Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA|
|São paulo, Brazil, 05437-010|
|Hospital Santa Marcelina|
|São Paulo, Brazil, 08270-070|
|Faculdade de Medicina ABC|
|São Paulo, Brazil, 0960-650|
|Principal Investigator:||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|