A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
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.
|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.
|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)|
Active Comparator: Tandrilax
Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
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
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.
|Hospital São Luiz||Not yet recruiting|
|São Paulo, Brazil, 05673-050|
|Contact: Rogerio T. Silva 551181716767 email@example.com|
|Principal Investigator:||Rogerio T. Silva, Phd||Hospital São Luiz|