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A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Imrecoxib
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Second Affiliated Hospital of Sun Yat-Sen University
  • Cangzhou Central Hospital
  • Tongji Hospital
  • The First People's Hospital of Lianyungang
  • Nanjing Drum Tower Hospital
  • Shengjing Hospital of China Medical University
  • Qilu Hospital of Shandong University
  • Qianfoshan Hospital Affiliated to Shandong University
  • The Second Hospital of Shangdong University
  • Zhejiang Provincial People's Hospital
  • Taizhou Hospital
  • BeijingChao-YangHospital
  • China-Japan Friendship Hospital
  • Peking University First Hospital
  • Beijing Hospital of the Ministry of Health
  • Peking Union Medical College Hospita
  • Peking University Third Hospital
  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
  • Tianjin First Center Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imrecoxib

Arm Description

0.1g,BID,po

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 2013
Last Updated
November 7, 2013
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01985165
Brief Title
A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis
Official Title
A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imrecoxib
Arm Type
Experimental
Arm Description
0.1g,BID,po
Intervention Type
Drug
Intervention Name(s)
Imrecoxib
Primary Outcome Measure Information:
Title
Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0
Time Frame
Baseline to Week 24
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
Baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengchun Zhang, Professor
Organizational Affiliation
Peking Union Medical College Hospita
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
Cangzhou Central Hospital
City
Cangzhou
State/Province
Hebei
Country
China
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
The First People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222002
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Facility Name
Qianfoshan Hospital Affiliated to Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
Facility Name
The Second Hospital of Shangdong University
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Zhejiang Provincial People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Taizhou Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Facility Name
BeijingChao-YangHospital
City
Beijing
ZIP/Postal Code
100020
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Hospital of the Ministry of Health
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking Union Medical College Hospita
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Tianjin First Center Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Learn more about this trial

A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

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