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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.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of Knee Drug: Pelubiprofen CR 45mg tab. Drug: Aceclofenac 100mg tab. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : August 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Aceclofenac

Arm Intervention/treatment
Active Comparator: test Drug: Pelubiprofen CR 45mg tab.
Active Comparator: reference Drug: Aceclofenac 100mg tab.



Primary Outcome Measures :
  1. Change from baseline 100mm Pain VAS at 4weeks [ Time Frame: 4weeks ]

Secondary Outcome Measures :
  1. Change from baseline 100mm Pain VAS at 2weeks [ Time Frame: 2weeks ]
  2. Change from baseline K-WOMAC Scale at 2weeks and 4weeks [ Time Frame: 2weeks, 4weeks ]
  3. Patient Global Assessment [ Time Frame: 4weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682524


Locations
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Korea, Republic of
Inha university hospital
Chung gu, Incheon, Korea, Republic of
Sponsors and Collaborators
Daewon Pharmaceutical Co., Ltd.
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Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02682524    
Other Study ID Numbers: DW_PlbCR_401
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Aceclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents