♦Basic information
JapicCTI-No. JapicCTI-111693
♦Title of the study
Title of the study Phase3 Study of SFPP in Patients with Osteoarthritis of the knee (Randomized, Parallel Group, Active Comparator-Controlled Study)
Public title of the study
Primary sponsor Taisho Pharmaceutical co., LTD
Secondary sponsor TOKUHON Corporation
Study Type interventional (drug)
Summary To evaluate the efficacy and safety of SFPP compared with FP gel patches in patients with osteoarthritis of the knee.
♦Details of the study
Disease or condition Osteoarthritis of the knee
Intervention
Intervention name SFPP
Classification name(code) of the intervention 264 (analgesics,anti-itchings,astrigents and anti-inflammatory agents)
Dosage And administration of the intervention Once a day
Control intervention name(code)/td> FP gel patches
Classification name(code) of the control intervention 264 (analgesics,anti-itchings,astrigents and anti-inflammatory agents)
Dosage And administration of the control intervention Twice a day
Objectives of the study Treatment
Study phase Phase 3
Study design Multicenter, Randomized, Parallel Group, Active Comparator-controlled Study
Target sample size 620
Inclusion Criteria - Outpatient able to walk
- Patients who agreed to X-ray diagnosis criteria: Kellegren-Lawrence grade 2-3.

etc.


AgeF     20years old or more
SexF     Both
Exclusion Criteria - History of surgery on the knee joint (including arthroscopy).
- Having critical hepatic disease, renal disease, heart disease and hematologic disease and malignant tumor.

etc.


Outcome
Primary Outcome Assessment of pain on a Visual Analogue Scale (VAS)
Timepoints
Secondary Outcome Changes in clinical symptoms , General Improvement Rating
Timepoints
Institutions
Duration of the study 2011-11-1  ` 
Study status Completed
recruitment status Study Completed
Region Japan
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Taisho Pharmaceutical Co., Ltd
Division Clinical Research
Contact person or e-mail address etc. Clinical-trials@po.rd.taisho.co.jp
Organization@(Scientific) Taisho Pharmaceutical Co., Ltd
Division@(Scientific) Clinical Research
Contact person or e-mail address etc.@(Scientific) Clinical-trials@po.rd.taisho.co.jp
♦Other
Source funded
Name of research funds
Other
♦History
History
2014/5/29   revised
2013/11/7   revised
2012/5/25   revised
2011/11/11   application date