A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoar... | NCT01985165

Studies
A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

NCT01985165

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Status

Unknown status

Last Update Posted

Nov 15, 2013Estimated

Enrollment

2,400Estimated

Phase

Phase 4

Conditions

Knee Osteoarthritis

Interventions

Imrecoxib

Countries

China

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Nov 2013Estimated

Completion Date

Not provided

First Submitted Date

Nov 1, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 15, 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

Nov 7, 2013

Last Update Posted Date

Nov 15, 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

The purpose of this study is to evaluate the efficacy and safety of Imrecoxib in the treatment of patients with knee osteoarthritis.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,400Estimated

Label	Type	Description	Intervention Names
Imrecoxib	Experimental	0.1g,BID,po	Drug: Imrecoxib

Name	Type	Description	Arm Group Labels	Other Names
Imrecoxib	Drug		Imrecoxib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0		Baseline to Week 24
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Baseline to week 24

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged form 18 years to 75 years old
Diagnosed with osteoarthritis of the knee according to the American College of Rheumatology
Functional capacity class of Ⅰ-Ⅲ

Exclusion Criteria:

Unstable angina
History of myocardial infarction within the last 6 months
Stroke in the 6 months before screening
New York Heart Association class Ⅲ-Ⅳ congestive heart-failure
Systolic blood pressure>180mmHg,and/or Diastolic blood pressure>100mmHg
Peptic ulcer
Known contraindications to non-steroidal anti-inflammatory drug（NSAID）
Received aspirin within 3 days of baseline visit
Aspirin dosage>150mg/d
Known to be Allergic to sulfa and COX-2 inhibitors
Pregnancy or lactation
Glutamic-oxaloacetic transaminase and/or glutamic-pyruvic transaminase>2 times upper limit of normal
Blood urine nitrogen>1.5 times upper limit of normal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fengchun Zhang, Professor	Peking Union Medical College Hospita	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Sun Yat-Sen University		Guangzhou	Guangdong		China
Cangzhou Central Hospital

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C488833	Imrecoxib

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided