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

Primary Purpose

Acute Lumbago

Status

Withdrawn

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

meloxicam/cyclobenzaprine hydrochloride

meloxicam - Movatec®

cyclobenzaprine - Miosan®

About this trial

This is an interventional treatment trial for Acute Lumbago

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

meloxicam - Movatec®

cyclobenzaprine - Miosan®,

meloxicam/cyclobenzaprine hydrochloride

Arm Description

Outcomes

Primary Outcome Measures

Pain Reduction

Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment.

Secondary Outcome Measures

Frequency of rescue medication use

Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment;

Full Information

NCT ID

NCT01587508

First Posted

April 24, 2012

Last Updated

April 29, 2016

Sponsor

Eurofarma Laboratorios S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01587508

Brief Title

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

Official Title

A Phase III, Randomized, Single-Blind, Superiority Study Comparing The Efficacy And Tolerability Of A New Drug Containing The Combination Meloxicam And Cyclobenzaprine And The Same Components Alone In The Treatment Of Acute Lumbago

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Withdrawn

Why Stopped

The comparator product was withdrawn from the brazilian market not being possible to conduct the design regarding initially planned.

Study Start Date

May 2013 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

To assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the same components alone. Some eligibility criteria: Have a normal X-ray of the lumbar spine for the age; Have a baseline score in the VAS higher than or equal to 40 mm

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Lumbago

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

meloxicam - Movatec®

Arm Type

Active Comparator

Arm Title

cyclobenzaprine - Miosan®,

Arm Type

Active Comparator

Arm Title

meloxicam/cyclobenzaprine hydrochloride

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

meloxicam/cyclobenzaprine hydrochloride

Intervention Description

two oral capsules a day during approximately 07 days

Intervention Type

Drug

Intervention Name(s)

meloxicam - Movatec®

Intervention Description

two oral tablet a day during approximately 07 days

Intervention Type

Drug

Intervention Name(s)

cyclobenzaprine - Miosan®

Intervention Description

two oral tablet a day during approximately 07 days

Primary Outcome Measure Information:

Title

Pain Reduction

Description

Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment.

Time Frame

Pain reduction 3 days after the administration of study drugs

Secondary Outcome Measure Information:

Title

Frequency of rescue medication use

Description

Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment;

Time Frame

During study treatment, an expected average of 7days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials: