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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01421433

Enrollment

160

Registered

2011-08-22

Start date

2012-05-31

Completion date

2013-01-31

Last updated

2012-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Clonixin, Anti-Inflammatory Agents, Non-Steroidal, Cyclooxygenase Inhibitors, Lysine, L-Lysine, Lysine Acetate, Lysine Hydrochloride, Amitriptyline

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.

Interventions

DRUGTandrilax

Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.

DRUGDolamin Flex

Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain average reduction	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

Measure	Time frame	Description
Identification of possible gastrointestinal effects	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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026