A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Low Back Pain |
Drug: Tandrilax Drug: Dolamin Flex |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
- Pain average reduction [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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.
- Identification of possible gastrointestinal effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
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.
| Estimated Enrollment: | 160 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Tandrilax
Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
|
Drug: Tandrilax
Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
Other Name: Tandrilax
|
|
Experimental: Dolamin Flex
Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)
|
Drug: Dolamin Flex
Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.
Other Name: Dolamin Flex
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01421433
| Brazil | |
| Hospital São Luiz | Not yet recruiting |
| São Paulo, Brazil, 05673-050 | |
| Contact: Rogerio T. Silva 551181716767 rogerio@neo.org.br | |
| Principal Investigator: | Rogerio T. Silva, Phd | Hospital São Luiz |
More Information
No publications provided
| Responsible Party: | Farmoquimica S.A. |
| ClinicalTrials.gov Identifier: | NCT01421433 History of Changes |
| Other Study ID Numbers: | FQM 01/11 |
| Study First Received: | August 18, 2011 |
| Last Updated: | March 7, 2012 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Keywords provided by Farmoquimica S.A.:
|
Clonixin Anti-Inflammatory Agents, Non-Steroidal Cyclooxygenase Inhibitors Lysine |
L-Lysine Lysine Acetate Lysine Hydrochloride Amitriptyline |
Additional relevant MeSH terms:
|
Carisoprodol Cyclobenzaprine Diclofenac Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Antidepressive Agents Antidepressive Agents, Tricyclic Antirheumatic Agents Central Nervous System Agents Central Nervous System Depressants |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Sensory System Agents Therapeutic Uses Tranquilizing Agents |
ClinicalTrials.gov processed this record on February 27, 2015