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

Overview

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.

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Investigator)
• Study Primary Completion Date: August 2012

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.

Interventions

• Drug: Tandrilax
  • Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
• Drug: Dolamin Flex
  • Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.

Arms, Groups and Cohorts

• Active Comparator: Tandrilax
  • Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
• Experimental: Dolamin Flex
  • Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)

Clinical Trial Outcome Measures

Primary Measures

• Pain average reduction
  • Time Frame: 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 Measures

• Identification of possible gastrointestinal effects
  • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Farmoquimica S.A.
• Collaborator
  • Pharmagenix Projetos em Medicina Farmacêutica Ltda.
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Rogerio T. Silva, Phd, Principal Investigator, Hospital São Luiz