Comparative Study of Loxoprofen Sodium Transdermal Patch and Loxonin® Tablets for the Treatment of Acute Trauma

PHASE3CompletedINTERVENTIONAL
Enrollment

242

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
TraumaPain
Interventions
DRUG

Transdermal Patch

Transdermal patch 100 mg once a day for 7 days

DRUG

Loxoprofen sodium

Loxoprofen sodium 60 mg per tablet by mouth, every 8 hours for 7 days

DRUG

Placebo (for loxoprofen sodium)

Placebo (for loxoprofen sodium 60 mg per tablet) by mouth, every 8 hours for 7 days

DRUG

Placebo (for transdermal patch)

Placebo (for transdermal patch 100 mg) once a day for 7 days

Trial Locations (8)

40170-150

Ctd Clinica de Terapia Da Dor Ltda, Salvador

74020-010

Med Centro de Estudos- Crd- Centro, Goiânia

36010-570

CMiP - Centro Mineiro de Pesquisa, Juiz de Fora

99010-080

Hospital São Vicente de Paulo, Passo Fundo

09030-010

HMCG - Hospital e Maternidade Dr. Christovão da Gama, Santo André

09060-650

Faculdade de Medicina do ABC, Santo André

15090-000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

02189-010

Hospital Nipo-Brasileiro, São Paulo

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

collaborator

Daiichi Sankyo Co., Ltd.

INDUSTRY

lead

Daiichi Sankyo Brasil Farmacêutica LTDA

INDUSTRY