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

Osteoarthritis of Knee Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682524
• Other study ID #: DW_PlbCR_401
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2015
• Last updated: October 7, 2016
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Pelubiprofen CR 45mg tab.

• Aceclofenac 100mg tab.

Locations

Country	Name	City	State
Korea, Republic of	Inha university hospital	Chung gu	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline 100mm Pain VAS at 4weeks		4weeks	No
Secondary	Change from baseline 100mm Pain VAS at 2weeks		2weeks	No
Secondary	Change from baseline K-WOMAC Scale at 2weeks and 4weeks		2weeks, 4weeks	No
Secondary	Patient Global Assessment		4weeks	No