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

NCT01421433 | Unknown Phase 3

• 1 other identifier: FQM 01/11
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

Clonixin; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Lysine; L-Lysine; Lysine Acetate; Lysine Hydrochloride; Amitriptyline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identification of possible gastrointestinal effects

  7 days

Study Arms (2)

Tandrilax

ACTIVE COMPARATOR

Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)

Drug: Tandrilax

Dolamin Flex

EXPERIMENTAL

Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)

Drug: Dolamin Flex

Interventions

Tandrilax DRUG

Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.

Tandrilax

Dolamin Flex DRUG

Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.

Dolamin Flex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Farmoquimica S.A.: lead
• Pharmagenix Projetos em Medicina Farmacêutica Ltda.: collaborator

Study Sites (1)

Hospital São Luiz

São Paulo, São Paulo, 05673-050, Brazil

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rogerio T. Silva, Phd

  Hospital São Luiz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 22, 2011
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

BR (1)