Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain (Dextra)
This study has been completed.
Sponsor:
Eurofarma Laboratorios S.A.
Information provided by:
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01147289
First received: June 16, 2010
Last updated: May 14, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Lumbar Sciatic Pain |
Drug: Dextralgen Drug: Meloxicam |
Phase 3 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Hydroxocobalamin
Meloxicam
U.S. FDA Resources
Further study details as provided by Eurofarma Laboratorios S.A.:
Primary Outcome Measures:
- 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.
| Enrollment: | 280 |
| Study Start Date: | February 2011 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: dexalgen
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
|
Drug: Dextralgen
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.
|
Drug: Meloxicam
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147289
Locations
| Brazil | |
| CEDOES | |
| 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 | |
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Estela Bellini Pannuti, Eurofarma Laboratorios Ltda |
| ClinicalTrials.gov Identifier: | NCT01147289 History of Changes |
| Other Study ID Numbers: | EF 102 |
| Study First Received: | June 16, 2010 |
| Last Updated: | May 14, 2012 |
| Health Authority: | Brazil: Ethics Committee Brazil: National Health Surveillance Agency |
Keywords provided by Eurofarma Laboratorios S.A.:
|
lumbar sciatic pain moderate to severe lumbar sciatic pain within the last three days |
Additional relevant MeSH terms:
|
Dexamethasone acetate Meloxicam Dexamethasone Dipyrone Dexamethasone 21-phosphate BB 1101 Hydroxocobalamin Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Antirheumatic Agents Vitamin B Complex |
ClinicalTrials.gov processed this record on May 19, 2013