Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rhe... | NCT01781702

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

NCT01781702

Sponsor

Daewon Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Aug 9, 2013Estimated

Enrollment

120Actual

Phase

Phase 3

Conditions

Pelubiprofen
Celebrex
Rheumatoid Arthritis

Interventions

Pelubiprofen 30 mg
Celebrex 200 mg

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 30, 2013

First Submission Date that Met QC Criteria

Jan 30, 2013

First Posted Date

Feb 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2013

Last Update Posted Date

Aug 9, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pelubiprofen 30 mg	Experimental	Pelubiprofen 30 mg, tid	Drug: Pelubiprofen 30 mg
Celebrex 200 mg	Active Comparator	Celebrex 200 mg, tid	Drug: Celebrex 200 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pelubiprofen 30 mg	Drug		Pelubiprofen 30 mg
Celebrex 200 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in '100 mm pain VAS' value from baseline		-14, 0, 14, 28, 42 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients who belong to ACR functional class 4
Patients who are hypersensitive to clinical trial medicines or excipient
Patients who have experience of Cerebrovascular bleeding, bleeding disorder

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25403311	Derived	Choi IA, Baek HJ, Cho CS, Lee YA, Chung WT, Park YE, Lee YJ, Park YB, Lee J, Lee SS, Yoo WH, Song JS, Kang SW, Kim HA, Song YW. Comparison of the efficacy and safety profiles of a pelubiprofen versus celecoxib in patients with rheumatoid arthritis: a 6-week, multicenter, randomized, double-blind, phase III, non-inferiority clinical trial. BMC Musculoskelet Disord. 2014 Nov 18;15:375. doi: 10.1186/1471-2474-15-375.

Type	Date	Date Unknown
Release	Mar 26, 2015
Reset	Apr 3, 2015

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

ID	Term
C040375	pelubiprofen
D000068579	Celecoxib

ID	Term
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals