TT063 STUDY

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Prodia Diacro Laboratories, PT (CRO)
No Registry
INA-H9W8EPN
Tanggal Input Registry : 05-02-2018

05-02-2018
Outcome Name: Improvement of Knee pain on rising from the chair Metric/method of measurement: Visual Analogue Score (VAS) Timepoint: 5 weeks (from 3 weeks of observation period and follow up with 2 weeks treatment period)
Outcome Name: Improvement of Changes in total clinical symptom (Pain symptom, Inflammatory symptoms and Impaired ADL) Metric/method of measurement: Assessment from Investigator Timepoint: 5 weeks (from 3 weeks of observation period and follow up with 2 weeks treatment period) Outcome Name: Improvement of Investigator's global assessment Metric/method of measurement: Investigator's global assessment Questionnaire Timepoint: 5 weeks (from 3 weeks of observation period and follow up with 2 weeks treatment period) Outcome Name: Improvement of Patient's global assessment Metric/method of measurement: Patient's global assessment Questionnaire Timepoint: 5 weeks (from 3 weeks of observation period and follow up with 2 weeks treatment period) Outcome Name: Improvement of Knee pain on walking Metric/method of measurement: Visual Analogue Score (VAS) Timepoint: 5 weeks (from 3 weeks of observation period and follow up with 2 weeks treatment period) Outcome Name: Number of Rescue drug use on treatment period Metric/method of measurement: Report from investigator Timepoint: 2 weeks on treatment period Outcome Name: Adverse drug reaction, Laboratory test and physical examination Metric/method of measurement: Report and assessment from investigator Timepoint: 2 weeks on treatment period
 
TT063 STUDY
Phase 3 Study of SFPP in Knee Osteoarthritis - a randomized controlled study using diclofenac gel as the comparator
Observasional
The following 2 groups are examined. The subjects are randomly allocated to these groups at the ratio of 1:1. SFPP group: One patch of SFPP is applied to the assessed knee once daily. Diclofenac (DC) group: Two gram of diclofenac gel per application is applied to the assessed knee 4 times daily. Pre-treatment Drugs: Patients take celecoxib 200 mg per day prescribed by investigator from screening visit (1st visit) to washout visit (2nd visit) as the pre-treatment for knee OA. Rescue Drugs: Use of paracetamol 1,000 mg once daily as the rescue drugs for knee pain is permitted from washout visit (2nd visit) to the end of final tests and observation only when the subjects cannot tolerate their knee pain (ex. they cannot rise up from chair). [Exception] Rescue drugs cannot be used within two days before the scheduled site visits.
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Inclusion Criteria:

1. Patients who had unilateral knee pain and were classified as Grade II or III according to Kellgren-Lawrence (KL) grading and whose non-assessed knee is not graded higher than the assessed knee based on x-ray in standing, weight-bearing extension position within 90 days before screening visit (1st visit) 2. Patients whose knee pain on rising from the chair assessed by visual analogue scale (rVAS) of the assessed knee meets all the following criteria for the level of pain; < 80 mm at washout visit (2nd visit), ≥ 40 mm at baseline visit (3rd visit), Worsening of ≥ 15 mm at baseline visit (3rd visit) compared with rVAS at washout visit (2nd visit) as a result of discontinuation of use of NSAIDs

Exclusion Criteria:

1. Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease
 
No. LB.04.01/A05/EC/305/X/2017, date 20Oct2017 from RSUP Dr. Hasan Sadikin Bandung; No. 901/UN2.F1/ETIK/2017 (02Oct2017), No. 934/UN2.F1/ETIK/2017 (09Oct2017), No. 935/UN2.F1/ETIK/2017 (09Oct2017), No. 936/UN2.F1/ETIK/2017 (09Oct2017), No. 937/UN2.F1/ETIK/2017 (09Oct2017), and No. 938/UN2.F1/ETIK/2017 (09Oct2017) from Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia.
NA
B-PN.01.06.313.3.12.17.6223; B-PN.01.06.313.3.12.17.6224; B-PN.01.06.313.3.12.17.6225; B-PN.01.06.313.3.12.17.6226; B-PN.01.06.313.3.12.17.6227; B-PN.01.06.313.3.12.17.6228; B-PN.01.06.313.3.12.17.6229
NA
Ni Putu Ardini, M.D. (email: Ardini.Kartasasmita@ma.taisho.co.id); Tomoyuki Inoue, Ph. D. (email: to-inoue@taisho.co.jp)