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

August 18, 2011
March 7, 2012
May 2012
August 2012   (final data collection date for primary outcome measure)
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.

Pain average reduction [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The metric that will be used is Pain Analog Visual Scale.
Complete list of historical versions of study NCT01421433 on ClinicalTrials.gov Archive Site
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.

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.
Not Provided
Not Provided
 
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • Drug: Tandrilax
    Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
    Other Name: Tandrilax
  • Drug: Dolamin Flex
    Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.
    Other Name: Dolamin Flex
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
January 2013
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Brazil
 
NCT01421433
FQM 01/11
No
Farmoquimica S.A.
Farmoquimica S.A.
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Principal Investigator: Rogerio T. Silva, Phd Hospital São Luiz
Farmoquimica S.A.
March 2012

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