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Acute Lumbago | Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

Acute Lumbago research study

What is the primary objective of this study?

The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.

Who is eligible to participate?

Inclusion Criteria: - Sign, initial and date the Informed Consent Form (ICF); - Be between 18 and 75 years old; - Have acute lumbago with onset in less than 72 hours; - Have a normal X-ray; - Have a baseline score in the VAS higher than or equal to 40 mm; Exclusion Criteria: - Use of triptans; - Use of monoamine oxidase inhibitors; - Use of NSAIDs within the last week; - Previous use of narcotics; - Have any rheumatologic disease; - Conditions of chronic pain; - Have any significant chronic comorbidity; - Previous history of gastrointestinal bleed or ulcers; - History of allergy to any of the components of study medications; - Recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure; - Female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study; - Have participated in another clinical trial within the last 12 months.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Acute Lumbago

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:meloxicam/cyclobenzaprine hydrochloridetwo oral capsules a day during approximately 07 days

Drug:meloxicam - Movatec®two oral tablet a day during approximately 07 days

Drug:cyclobenzaprine - Miosan®two oral tablet a day during approximately 07 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

meloxicam - Movatec®

cyclobenzaprine - Miosan®,

meloxicam/cyclobenzaprine hydrochloride

Study Status

Withdrawn

Start Date: May 2013

Completed Date: May 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Pain Reduction

Secondary Outcome: Frequency of rescue medication use

Study sponsors, principal investigator, and references

Principal Investigator: Alceu Chueiri

Lead Sponsor: Eurofarma Laboratorios S.A.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01587508

Discuss Cyclobenzaprine