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Low Back Pain | A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol

Low Back Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Low Back Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Unknown status

Start Date: May 2012

Completed Date: January 2013

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Pain average reduction

Secondary Outcome: Identification of possible gastrointestinal effects

Study sponsors, principal investigator, and references

Principal Investigator: Rogerio T. Silva, Phd

Lead Sponsor: Farmoquimica S.A.

Collaborator: Pharmagenix Projetos em Medicina FarmacĂȘutica Ltda.

More information:https://clinicaltrials.gov/show/NCT01421433

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