A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
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|ClinicalTrials.gov Identifier: NCT01421433|
Recruitment Status : Unknown
Verified March 2012 by Farmoquimica S.A..
Recruitment status was: Not yet recruiting
First Posted : August 22, 2011
Last Update Posted : March 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Tandrilax Drug: Dolamin Flex||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 2012|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||January 2013|
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.
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01421433
|Hospital São Luiz|
|São Paulo, Brazil, 05673-050|
|Contact: Rogerio T. Silva 551181716767 firstname.lastname@example.org|
|Principal Investigator:||Rogerio T. Silva, Phd||Hospital São Luiz|