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

Overview[ - collapse ][ - ]

Purpose A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
ConditionPelubiprofen
Celebrex
Rheumatoid Arthritis
InterventionDrug: Pelubiprofen 30 mg
Drug: Celebrex 200 mg
PhasePhase 3
SponsorDaewon Pharmaceutical Co., Ltd.
Responsible PartyDaewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov IdentifierNCT01781702
First ReceivedJanuary 30, 2013
Last UpdatedAugust 7, 2013
Last verifiedAugust 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 30, 2013
Last Updated DateAugust 7, 2013
Start DateOctober 2010
Estimated Primary Completion DateOctober 2011
Current Primary Outcome MeasuresChanges in '100 mm pain VAS' value from baseline [Time Frame: -14, 0, 14, 28, 42 day] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitlePhase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
Official TitleA Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
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
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Condition
  • Pelubiprofen
  • Celebrex
  • Rheumatoid Arthritis
InterventionDrug: Pelubiprofen 30 mg
Drug: Celebrex 200 mg
Study Arm (s)
  • Experimental: Pelubiprofen 30 mg
    Pelubiprofen 30 mg, tid
  • Active Comparator: Celebrex 200 mg
    Celebrex 200 mg, tid

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment120
Estimated Completion DateOctober 2011
Estimated Primary Completion DateOctober 2011
Eligibility 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
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesNot Provided

Administrative Information[ + expand ][ + ]

NCT Number NCT01781702
Other Study ID NumbersDW Plb RA301
Has Data Monitoring CommitteeYes
Information Provided ByDaewon Pharmaceutical Co., Ltd.
Study SponsorDaewon Pharmaceutical Co., Ltd.
CollaboratorsNot Provided
Investigators Not Provided
Verification DateAugust 2013