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

Sponsor

Farmoquimica S.A. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01421433

Collaborator

Pharmagenix Projetos em Medicina Farmacêutica Ltda. (Other)

160

Enrollment

Location

Arms

Duration (Months)

19.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: Tandrilax Drug: Dolamin Flex	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2012

Anticipated Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.