Acute LumbagoPhase 3NCT01587508

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

A Phase 3 study testing meloxicam/cyclobenzaprine hydrochloride, meloxicam - Movatec® and cyclobenzaprine - Miosan® in people with Acute Lumbago, run by Eurofarma Laboratorios S.A. at 11 sites in Brazil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Acute Lumbago
What is being tested?: meloxicam/cyclobenzaprine hydrochloride, meloxicam - Movatec® and cyclobenzaprine - Miosan®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 11 sitesBrazil
Study dates: May 2013to May 2013
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

Who cannot join

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;

Show all 12Show fewer

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.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Brazil11 sites

Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais
CIP Pesquisas Médicas Ltda
Goiânia, Goiás
Clínica de Ortopedia e Fraturas de Goiânia
Goiânia, Goiás
Santa Casa de Juíz de Fora
Juiz de Fora, Minas Gerais
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul
Faculdade de Medicina ABC
Santo André, São Paulo
Hospítal de Base
São José Rio Preto, São Paulo
Clinica de Ortopedia e Fisiatria Perdizes
São Paulo, São Paulo
Hospital Santa Marcelina
São Paulo, São Paulo
IMA Brasil
São Paulo, São Paulo
Santa Casa de Votuporanga
Votuporanga, São Paulo

Other trials in Brazil

About this study

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

Read the 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

Conditions: Acute Lumbago
Being tested: meloxicam/cyclobenzaprine hydrochloride, meloxicam - Movatec®, cyclobenzaprine - Miosan®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

meloxicam/cyclobenzaprine hydrochlorideDrug
two oral capsules a day during approximately 07 days
meloxicam - Movatec®Drug
two oral tablet a day during approximately 07 days
cyclobenzaprine - Miosan®Drug
two oral tablet a day during approximately 07 days

Study groups in NCT01587508
Study group	Role	What they receive
meloxicam - Movatec®	Active comparator	Not described Receives: Drug: meloxicam - Movatec®
cyclobenzaprine - Miosan®,	Active comparator	Not described Receives: Drug: cyclobenzaprine - Miosan®
meloxicam/cyclobenzaprine hydrochloride	Experimental	Not described Receives: Drug: meloxicam/cyclobenzaprine hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Pain reduction 3 days after the administration of study drugs

Secondary outcomes (1)

Frequency of rescue medication use
Assessment of frequency of rescue medication use, as well as the proportion of patients during study treatment;
Measured: During study treatment, an expected average of 7days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013May 2013

First posted30 Apr 2012 (estimated)
Study startMay 2013
Primary completionMay 2013
Study completionMay 2013

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute LumbagoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01587508
Sponsor's protocol ID: EF 127
Status last verified: Apr 2012
First submitted: 24 Apr 2012
Last updated: 3 May 2016
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Not yet recruiting
Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
Recruiting
Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial
Non-traumatic Low Back Pain
RecruitingObservational study
Exploring Multidimensional Trajectories in People With Low Back Pain
Acute Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)

All Acute Lumbago trials

Study at a glance

From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01587508
Acronym / sponsor ID: EF 127
Conditions: Acute Lumbago
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The comparator product was withdrawn from the brazilian market not being possible to conduct the design regarding initially planned.
Enrolment: 0 participants (actual)
Lead sponsor: Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
Study start: May 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 30 Apr 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
meloxicam - Movatec®	Active comparator	Drug: meloxicam - Movatec®
cyclobenzaprine - Miosan®,	Active comparator	Drug: cyclobenzaprine - Miosan®
meloxicam/cyclobenzaprine hydrochloride	Experimental	Drug: meloxicam/cyclobenzaprine hydrochloride

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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;

Key exclusion criteria (12 listed)

Use of triptans;
Use of monoamine oxidase inhibitors;
Use of NSAIDs within the last week;
Previous use of narcotics;
Have any rheumatologic disease;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
meloxicam/cyclobenzaprine hydrochloridetwo oral capsules a day during approximately 07 days	Drug	meloxicam/cyclobenzaprine hydrochloride
meloxicam - Movatec®two oral tablet a day during approximately 07 days	Drug	meloxicam - Movatec®
cyclobenzaprine - Miosan®two oral tablet a day during approximately 07 days	Drug	cyclobenzaprine - Miosan®,

Primary outcome

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

1 secondary outcome

Frequency of rescue medication use
Time frame: During study treatment, an expected average of 7days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.

Related trials for Acute Lumbago

Recruiting
Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.
Back Pain Lower Back Chronic
Not yet recruiting
Preventing the Transition From Acute to Persistent Disabling Low Back Pain Through Cognitive Functional Therapy
Acute Low Back Pain (Low Back Pain for Less Than 3 Months)
Recruiting
Comprehensive Biopsychosocial Approach for Acute Low Back Pain Management in the Emergency Department: a Stepped-wedge Cluster-randomized Clinical Trial
Non-traumatic Low Back Pain
RecruitingObservational study
Exploring Multidimensional Trajectories in People With Low Back Pain
Acute Low Back Pain, Chronic Low Back Pain (CLBP)
Not yet recruiting
Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain
Low Back Pain (LBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alceu Chueiri principal investigator

Hospital de Base de São José do Rio Preto

Paulo Guilherme principal investigator

Hospital Santa Marcelina

Wagner Caiafa principal investigator

Santa Casa de Juiz de Fora

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Reduction (time frame: Pain reduction 3 days after the administration of study drugs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01587508.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.