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Trial record 3 of 8 for:    CARISOPRODOL

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.
 
ClinicalTrials.gov 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
Sponsor:
Collaborator:
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A.

Tracking Information
First Submitted Date  ICMJE August 18, 2011
First Posted Date  ICMJE August 22, 2011
Last Update Posted Date March 8, 2012
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
Pain average reduction [ Time Frame: 7 days ]
The metric that will be used is Pain Analog Visual Scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2012)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2011)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • Drug: Tandrilax
    Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
  • Drug: Dolamin Flex
    Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.
Study Arms  ICMJE
  • Active Comparator: Tandrilax
    Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
    Intervention: Drug: Tandrilax
  • Experimental: Dolamin Flex
    Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)
    Intervention: Drug: Dolamin Flex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 19, 2011)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01421433
Other Study ID Numbers  ICMJE FQM 01/11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Farmoquimica S.A.
Study Sponsor  ICMJE Farmoquimica S.A.
Collaborators  ICMJE Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Investigators  ICMJE
Principal Investigator: Rogerio T. Silva, Phd Hospital São Luiz
PRS Account Farmoquimica S.A.
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP