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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Tandrilax; Drug: Dolamin Flex

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: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05673-050
    • Hospital Sao Luiz
    • Contact: Rogerio T. Silva; Phone Number: 551181716767; Email: rogerio@neo.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain average reduction	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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of possible gastrointestinal effects	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.	7 days

Collaborators and Investigators

• Sponsor: Farmoquimica S.A.
• Collaborators: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
• Investigators: Principal Investigator: Rogerio T. Silva, Phd, Hospital Sao Luiz

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): January 1, 2013

Study Registration Dates

• First Submitted: August 18, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (Estimate): August 22, 2011

Study Record Updates

• Last Update Posted (Estimate): March 8, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Anti-Inflammatory Agents, Non-Steroidal; Amitriptyline; Lysine; Cyclooxygenase Inhibitors; Clonixin; L-Lysine; Lysine Acetate; Lysine Hydrochloride
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: FQM 01/11