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Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02682524
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 12, 2015
First Posted Date  ICMJE February 15, 2016
Last Update Posted Date October 10, 2016
Study Start Date  ICMJE August 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
Change from baseline 100mm Pain VAS at 4weeks [ Time Frame: 4weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2016)
  • Change from baseline 100mm Pain VAS at 2weeks [ Time Frame: 2weeks ]
  • Change from baseline K-WOMAC Scale at 2weeks and 4weeks [ Time Frame: 2weeks, 4weeks ]
  • Patient Global Assessment [ Time Frame: 4weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Official Title  ICMJE Not Provided
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis of Knee
Intervention  ICMJE
  • Drug: Pelubiprofen CR 45mg tab.
  • Drug: Aceclofenac 100mg tab.
Study Arms  ICMJE
  • Active Comparator: test
    Intervention: Drug: Pelubiprofen CR 45mg tab.
  • Active Comparator: reference
    Intervention: Drug: Aceclofenac 100mg tab.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2016)
191
Original Estimated Enrollment  ICMJE
 (submitted: February 10, 2016)
190
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02682524
Other Study ID Numbers  ICMJE DW_PlbCR_401
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daewon Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Daewon Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daewon Pharmaceutical Co., Ltd.
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP