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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01421433
• Other study ID #: FQM 01/11
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 18, 2011
• Last updated: March 7, 2012
• Start date: May 2012
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: Farmoquimica S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital São Luiz	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Farmoquimica S.A.	Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes