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
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A.
ClinicalTrials.gov Identifier:
First received: August 18, 2011
Last updated: March 7, 2012
Last verified: March 2012
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:

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.

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

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

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.
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.:
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Lysine Acetate
Lysine Hydrochloride

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antirheumatic Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central

ClinicalTrials.gov processed this record on May 25, 2016