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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421433
Recruitment Status : Unknown
Verified March 2012 by Farmoquimica S.A..
Recruitment status was:  Not yet recruiting
First Posted : August 22, 2011
Last Update Posted : March 8, 2012
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A.

Brief Summary:
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 or disease Intervention/treatment Phase
Low Back Pain Drug: Tandrilax Drug: Dolamin Flex Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Pain average reduction [ Time Frame: 7 days ]

    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 :
  1. Identification of possible gastrointestinal effects [ Time Frame: 7 days ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421433

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Hospital São Luiz
São Paulo, Brazil, 05673-050
Contact: Rogerio T. Silva    551181716767   
Sponsors and Collaborators
Farmoquimica S.A.
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
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Principal Investigator: Rogerio T. Silva, Phd Hospital São Luiz
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Responsible Party: Farmoquimica S.A. Identifier: NCT01421433    
Other Study ID Numbers: FQM 01/11
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: March 8, 2012
Last Verified: March 2012
Keywords provided by Farmoquimica S.A.:
Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors
Lysine Acetate
Lysine Hydrochloride
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Neurologic Manifestations