Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01781702
First received: January 30, 2013
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients


Condition Intervention Phase
Pelubiprofen
Celebrex
Rheumatoid Arthritis
Drug: Pelubiprofen 30 mg
Drug: Celebrex 200 mg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients

Resource links provided by NLM:


Further study details as provided by Daewon Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Changes in '100 mm pain VAS' value from baseline [ Time Frame: -14, 0, 14, 28, 42 day ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pelubiprofen 30 mg
Pelubiprofen 30 mg, tid
Drug: Pelubiprofen 30 mg
Active Comparator: Celebrex 200 mg
Celebrex 200 mg, tid
Drug: Celebrex 200 mg

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult males/Females aged 18~80 years
  2. Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
  3. Patients who belong to ACR functional class 1, 2, 3

Exclusion Criteria:

  1. Patients who belong to ACR functional class 4
  2. Patients who are hypersensitive to clinical trial medicines or excipient
  3. Patients who have experience of Cerebrovascular bleeding, bleeding disorder
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01781702     History of Changes
Other Study ID Numbers: DW Plb RA301
Study First Received: January 30, 2013
Last Updated: August 7, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014