A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Information source: Farmoquimica S.A.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Low Back Pain
Intervention: Tandrilax (Drug); Dolamin Flex (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Farmoquimica S.A. Official(s) and/or principal investigator(s):
Rogerio T. Silva, Phd, Principal Investigator, Affiliation: Hospital São Luiz
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain average reduction
Secondary outcome: Identification of possible gastrointestinal effects
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Hospital São Luiz, São Paulo 05673-050, Brazil; Not yet recruiting
Rogerio T. Silva, Phone: 551181716767, Email: rogerio@neo.org.br
Additional Information
Starting date: May 2012
Last updated: March 7, 2012
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