drugset / Trial / NCT01421433
A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol
Phase 3
Unknown
160 enrolled
Farmoquimica S.A.
Pharmagenix Projetos em Medicina Farmacêutica Ltda. · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2012-05
- Primary completion
- 2012-08
- Completion
- 2013-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | — | Oral |
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Carisoprodol | Small molecule | — | Oral |
| Subject | Diclofenac | Other / unclassified | — | Oral |
| Subject | clonixinate | Unknown | — | Oral |
| Subject | cyclobenzaprine | Small molecule | — | Oral |
Indications
No indication recorded.