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

Lumbar Sciatic Pain Clinical Trial

— Dextra  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147289
• Other study ID #: EF 102
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2010
• Last updated: May 14, 2012
• Start date: February 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lumbar Sciatic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto De Pesquisa Clínica De Campinas IPECC	Campinas	São Paulo
Brazil	Sociedade Beneficente São Camilo	Campinas	São Paulo
Brazil	Faculdade de Medicina ABC	São Paulo
Brazil	Hospital Santa Marcelina	São Paulo
Brazil	Instituto de Pesquisa Clínica e Medicina Avançada Ltda IMA	São paulo
Brazil	CEDOES	Vitoria	Espirito Santo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes