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

NCT02682524 | Completed Phase 4

• 1 other identifier: DW_PlbCR_401
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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

Conditions

Osteoarthritis of Knee

Outcome Measures

Primary Outcomes (1)

• Change from baseline 100mm Pain VAS at 4weeks

  4weeks

Secondary Outcomes (3)

• Change from baseline 100mm Pain VAS at 2weeks

  2weeks

• Change from baseline K-WOMAC Scale at 2weeks and 4weeks

  2weeks, 4weeks

• Patient Global Assessment

  4weeks

Study Arms (2)

test

ACTIVE COMPARATOR

Drug: Pelubiprofen CR 45mg tab.

reference

ACTIVE COMPARATOR

Drug: Aceclofenac 100mg tab.

Interventions

Pelubiprofen CR 45mg tab. DRUG

test

Aceclofenac 100mg tab. DRUG

reference

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Inha university hospital

Chung Gu, Incheon, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

aceclofenac

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: February 15, 2016
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

KR (1)