Dextra: Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain

Sponsor

Eurofarma Laboratorios S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01147289

Collaborator

(none)

280

Enrollment

Locations

Arms

Duration (Months)

46.7

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Lumbar Sciatic Pain	Drug: Dextralgen Drug: Meloxicam	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

efficacy [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	CEDOES	Vitoria	Espirito Santo	Brazil	29055-450
2	Sociedade Beneficente São Camilo	Campinas	São Paulo	Brazil	05022-001
3	Instituto De Pesquisa Clínica De Campinas IPECC	Campinas	São Paulo	Brazil	13073-350
4	Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA	São paulo		Brazil	05437-010
5	Hospital Santa Marcelina	São Paulo		Brazil	08270-070
6	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01147289

Other Study ID Numbers:

EF 102

First Posted:

Jun 22, 2010

Last Update Posted:

May 15, 2012

Last Verified:

May 1, 2012

Keywords provided by , ,

lumbar sciatic pain

moderate to severe lumbar sciatic pain within the last three days

Additional relevant MeSH terms:

Meloxicam

Study Results

No Results Posted as of May 15, 2012