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

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Daewon Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Celebrex
Pelubiprofen
Rheumatoid Arthritis

Treatments

Drug: Celebrex 200 mg
Drug: Pelubiprofen 30 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01781702
DW Plb RA301

Details and patient eligibility

About

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

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

120 participants in 2 patient groups

Pelubiprofen 30 mg
Experimental group
Description:
Pelubiprofen 30 mg, tid
Treatment:
Drug: Pelubiprofen 30 mg
Celebrex 200 mg
Active Comparator group
Description:
Celebrex 200 mg, tid
Treatment:
Drug: Celebrex 200 mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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