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

• ClinicalTrials.gov Identifier: NCT01421433
• Recruitment Status: Unknown
• First Posted: August 22, 2011
• Last Update Posted: March 8, 2012
• Sponsor: Farmoquimica S.A.
• Collaborator: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
• Information provided by (Responsible Party): Farmoquimica S.A.

Tracking Information

• First Submitted Date: August 18, 2011
• First Posted Date: August 22, 2011
• Last Update Posted Date: March 8, 2012
• Study Start Date: May 2012
• Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2012)

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.

Original Primary Outcome Measures (submitted: August 19, 2011)

Pain average reduction [ Time Frame: 7 days ]

The metric that will be used is Pain Analog Visual Scale.

Current Secondary Outcome Measures (submitted: March 6, 2012)

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.

Original Secondary Outcome Measures (submitted: August 19, 2011)

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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
• 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
• 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Low Back Pain

Intervention

• 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.

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: August 19, 2011): 160
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2013
• Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT01421433
• Other Study ID Numbers: FQM 01/11
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Farmoquimica S.A.
• Study Sponsor: Farmoquimica S.A.
• Collaborators: Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Investigators

• Principal Investigator: Rogerio T. Silva, Phd; Hospital São Luiz

• PRS Account: Farmoquimica S.A.
• Verification Date: March 2012