Clinical trial NCT01604239: To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
Official title: A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Shinbaro
Herbal drug
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2012-05-23
Enrollment: 761
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Minimum 19 years old
* Kellgren stage I \~ III by ACR criteria
* Stable osteoarthritis during 3 months
* Be able to perform WOMAC and KKS
* Written consent form voluntarily

Exclusion Criteria:

* Disease of orthopaedic surgical that could affect to evaluate the efficacy
* Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
* Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
* Medical history of hypersensitivity reaction against Herbal drug
* Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
* Occurrence of OA caused by the injury
* Diagnosed with psychical disorder, and taking medication
* Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
* Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
* Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
* Positive in fecal occult blood test
* Gastrointestinal tract surgery except appendectomy
* Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
* Participation in another clinical trials within 4 weeks
* Not consent about using effectual contraception method during trial
* Pregnant or lactating woman
* Medical history of malignant tumor within 5 years
* Investigator's judgment

Primary outcomes:
measure: Percentage of subjects with gastrointestinal adverse events
timeFrame: Baseline through 24 weeks
Secondary outcomes:
measure: percentage of subjects with perforation, ulcer, bleeding
timeFrame: baseline throgh week 24
measure: percentage of subjects who withdrew due to GI AEs
timeFrame: baseline through week 24
measure: Frequency of AEs
timeFrame: baseline throgh week 24
measure: WOMAC change from baseline
timeFrame: 24 weeks
measure: KKS (Korean Knee Score) change from baseline
timeFrame: 24 weeks
measure: 100mm pain VAS on walking
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook national university hospital
state: Kyungpook
city: Bundang
country: Korea, Republic of
facility: BundangCha Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chonju
country: Korea, Republic of
facility: Chonbul National University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Deagu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Ilsan
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Inchun
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: GC Biopharma Corp
name: BG Lee
role: STUDY_CHAIR
References:
citation: Ha CW, Park YB, Kyung HS, Han CS, Bae KC, Lim HC, Park SE, Lee MC, Won YY, Lee DC, Cho SD, Kim CW, Kim JG, Kang JS, Lee JH, Choi ES, Seon JK, Lee WS, Bin SI. Gastrointestinal safety and efficacy of long-term GCSB-5 use in patients with osteoarthritis: A 24-week, multicenter study. J Ethnopharmacol. 2016 Aug 2;189:310-8. doi: 10.1016/j.jep.2016.05.031. Epub 2016 May 16.