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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781702
First Posted: February 1, 2013
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.
  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 (Participant, Care Provider)
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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01781702     History of Changes
Other Study ID Numbers: DW Plb RA301
First Submitted: January 30, 2013
First Posted: February 1, 2013
Last Update Posted: October 12, 2017
Last Verified: August 2013

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
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