ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT01781702
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : August 9, 2013
Sponsor:
Information provided by (Responsible Party):
Daewon Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Pelubiprofen Celebrex Rheumatoid Arthritis Drug: Pelubiprofen 30 mg Drug: Celebrex 200 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : October 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Changes in '100 mm pain VAS' value from baseline [ Time Frame: -14, 0, 14, 28, 42 day ]


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.


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

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 Posted: February 1, 2013    Key Record Dates
Last Update Posted: August 9, 2013
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