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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Drug: Tandrilax
* Drug: Dolamin Flex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tandrilax<br>Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol) | Drug: Tandrilax<br>* Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.<br>|
| Experimental: Dolamin Flex<br>Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine) | Drug: Dolamin Flex<br>* Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clonixin, Anti-Inflammatory Agents, Non-Steroidal, Cyclooxygenase Inhibitors, Lysine, L-Lysine, Lysine Acetate, Lysine Hydrochloride, Amitriptyline