A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2012 by Farmoquimica S.A..
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Information provided by (Responsible Party):

Farmoquimica S.A.

ClinicalTrials.gov Identifier:

NCT01421433

First received: August 18, 2011

Last updated: March 7, 2012

Last verified: March 2012

History of Changes

Purpose

Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.

Condition	Intervention	Phase
Low Back Pain	Drug: Tandrilax Drug: Dolamin Flex	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

Drug Information available for: Lysine Carisoprodol Acetaminophen Cyclobenzaprine Lysine hydrochloride Cyclobenzaprine hydrochloride Diclofenac sodium Diclofenac potassium Diclofenac Lysine acetate

U.S. FDA Resources

Further study details as provided by Farmoquimica S.A.:

Primary Outcome Measures:

Pain average reduction [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The metric that will be used is Pain Analog Visual Scale (PAVS), that it is a graphical representation with values 0-10.

To use the PAVS, the principal investigator should question the patient regarding their pain level, and the value 0 (zero) means no pain and the value 10 (ten) indicates the maximum pain level.

Secondary Outcome Measures:

Identification of possible gastrointestinal effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
The metric that will be used is checking the safety data reported by the patient in the Patient Diary and / or using data reported by patients by Phone Call.

A diary will be given for the patient, to make notes about possible gastrointestinal adverse events.

The principal investigator should call to the patient to know about possible gastrointestinal adverse effects of the drug.


Estimated Enrollment:	160
Study Start Date:	May 2012
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Tandrilax Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)	Drug: Tandrilax Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
Experimental: Dolamin Flex Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)	Drug: Dolamin Flex Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.

Detailed Description:

Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed of the nature of the study and given written informed consent
Patients with mild to moderate lumbago
Aged between 18 and 65 years old

Exclusion Criteria:

Known allergy or sensitivity to drug components
Treatment with another anti inflammatory or corticoid
Treatment with oral anticoagulants
Treatment with oxidase monoamine 2 weeks before the study
Treatment with methotrexate
Stomach or duodenal ulcer and gastritis
Dehydration
Acute myocardial infarction or heart failure
Hyperthyroidism
Pregnant or lactating patients
Treatment with lithium
User of alcohol and barbiturates
Hepatic or renal failure

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421433

Locations


Brazil
Hospital São Luiz	Not yet recruiting
São Paulo, Brazil, 05673-050
Contact: Rogerio T. Silva 551181716767 rogerio@neo.org.br

Sponsors and Collaborators

Farmoquimica S.A.

Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Investigators


Principal Investigator:	Rogerio T. Silva, Phd	Hospital São Luiz

More Information


Responsible Party:	Farmoquimica S.A.
ClinicalTrials.gov Identifier:	NCT01421433 History of Changes
Other Study ID Numbers:	FQM 01/11
Study First Received:	August 18, 2011
Last Updated:	March 7, 2012
Health Authority:	Brazil: National Health Surveillance Agency

Keywords provided by Farmoquimica S.A.:


Clonixin Anti-Inflammatory Agents, Non-Steroidal Cyclooxygenase Inhibitors Lysine	L-Lysine Lysine Acetate Lysine Hydrochloride Amitriptyline

Additional relevant MeSH terms:


Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Acetaminophen Diclofenac Amitriptyline Clonixin Caffeine Anti-Inflammatory Agents, Non-Steroidal Cyclobenzaprine Carisoprodol Analgesics, Non-Narcotic	Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Central Nervous System Stimulants Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Anti-Inflammatory Agents Antirheumatic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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