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

Phase 3

• Conditions: Low Back Pain
• Interventions: Drug: Tandrilax; Drug: Dolamin Flex

• Registration Number: NCT01421433
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-08
• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tandrilax	Tandrilax	Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
Dolamin Flex	Dolamin Flex	Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)

Primary Outcome Measures

Name	Time	Method
Pain average reduction	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

Name	Time	Method
Identification of possible gastrointestinal effects	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.

Trial Locations

Locations (1)

Hospital São Luiz; 🇧🇷 São Paulo, Brazil