Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis of Knee
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pelubiprofen CR 45mg tab.
Aceclofenac 100mg tab.
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis of Knee
Eligibility Criteria
Inclusion Criteria:
- both male and female who is over 35year-old and below 80year-old
- patient who diagnosed as Kellgren & Lawrence stage I~III by X-ray
- osteoarthritis patient who is stable within 3months form starting this clinical trial
- patient who is over 40mm in 100mm Pain VAS at Visit 2
- patient who agreed to participate this clinical trial spontaneously
Exclusion Criteria:
- second osteoarthritis
- patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc.
- patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy
- patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period
- patient who has had artificial joint surgery of knee
- malignant tumor patient
- patient who has taken Psychopharmaceutical or Narcotic Analgesics over 3months continuously
- patient who took steroid by oral, inhalation or intraarticular injection within 3months form screening visit of this clinical trial
- patient who took intraarticular hyaluronic acid injection of knee within 2months form screening visit of this clinical trial
- patient who cannot take NSAIDs because of disease or medicine
- allergy of aspirin of other NSAIDs
- patient who has to handle his/her pain by or for CABG
- galactose intolerance, Lactose Intolerance or glucose-galactose malabsorption
- inflammatory bowel disease such as ulcerative colitis or Crohn's disease
- moderate renal disease
- moderate hepatic disease
- moderate hypertension(SBP=>160mmHg, DBP=>100mmHg)
- female who consents to contracept
- patient who is not appropriate for this clinical trial
Sites / Locations
- Inha university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
test
reference
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline 100mm Pain VAS at 4weeks
Secondary Outcome Measures
Change from baseline 100mm Pain VAS at 2weeks
Change from baseline K-WOMAC Scale at 2weeks and 4weeks
Patient Global Assessment
Full Information
NCT ID
NCT02682524
First Posted
October 12, 2015
Last Updated
October 7, 2016
Sponsor
Daewon Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02682524
Brief Title
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewon Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
191 (Actual)
8. Arms, Groups, and Interventions
Arm Title
test
Arm Type
Active Comparator
Arm Title
reference
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pelubiprofen CR 45mg tab.
Intervention Type
Drug
Intervention Name(s)
Aceclofenac 100mg tab.
Primary Outcome Measure Information:
Title
Change from baseline 100mm Pain VAS at 4weeks
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
Change from baseline 100mm Pain VAS at 2weeks
Time Frame
2weeks
Title
Change from baseline K-WOMAC Scale at 2weeks and 4weeks
Time Frame
2weeks, 4weeks
Title
Patient Global Assessment
Time Frame
4weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
both male and female who is over 35year-old and below 80year-old
patient who diagnosed as Kellgren & Lawrence stage I~III by X-ray
osteoarthritis patient who is stable within 3months form starting this clinical trial
patient who is over 40mm in 100mm Pain VAS at Visit 2
patient who agreed to participate this clinical trial spontaneously
Exclusion Criteria:
second osteoarthritis
patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc.
patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy
patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period
patient who has had artificial joint surgery of knee
malignant tumor patient
patient who has taken Psychopharmaceutical or Narcotic Analgesics over 3months continuously
patient who took steroid by oral, inhalation or intraarticular injection within 3months form screening visit of this clinical trial
patient who took intraarticular hyaluronic acid injection of knee within 2months form screening visit of this clinical trial
patient who cannot take NSAIDs because of disease or medicine
allergy of aspirin of other NSAIDs
patient who has to handle his/her pain by or for CABG
galactose intolerance, Lactose Intolerance or glucose-galactose malabsorption
inflammatory bowel disease such as ulcerative colitis or Crohn's disease
moderate renal disease
moderate hepatic disease
moderate hypertension(SBP=>160mmHg, DBP=>100mmHg)
female who consents to contracept
patient who is not appropriate for this clinical trial
Facility Information:
Facility Name
Inha university hospital
City
Chung gu
State/Province
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
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