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A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

Sponsor
Jiangsu HengRui Medicine Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01985165
Collaborator
(none)
2,400
Enrollment
19
Locations
1
Arm
126.3
Patients Per Site

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imrecoxib

0.1g,BID,po

Drug: Imrecoxib

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Baseline to week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Sun Yat-Sen University Guangzhou Guangdong China
2 Cangzhou Central Hospital Cangzhou Hebei China
3 Tongji Hospital Wuhan Hubei China 430030
4 The First People's Hospital of Lianyungang Lianyungang Jiangsu China 222002
5 Nanjing Drum Tower Hospital Nanjing Jiangsu China
6 Shengjing Hospital of China Medical University Shenyang Liaoning China 110004
7 Qilu Hospital of Shandong University Jinan Shandong China 250012
8 Qianfoshan Hospital Affiliated to Shandong University Jinan Shandong China 250014
9 The Second Hospital of Shangdong University Jinan Shandong China
10 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China
11 Taizhou Hospital Taizhou Zhejiang China
12 BeijingChao-YangHospital Beijing China 100020
13 China-Japan Friendship Hospital Beijing China 100029
14 Peking University First Hospital Beijing China 100034
15 Beijing Hospital of the Ministry of Health Beijing China 100730
16 Peking Union Medical College Hospita Beijing China
17 Peking University Third Hospital Beijing China
18 Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Chongqing China 400042
19 Tianjin First Center Hospital Tianjin China

Sponsors and Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

Investigators

  • Principal Investigator: Fengchun Zhang, Professor, Peking Union Medical College Hospita

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01985165
Other Study ID Numbers:
  • HRARXB00434
First Posted:
Nov 15, 2013
Last Update Posted:
Nov 15, 2013
Last Verified:
Nov 1, 2013
Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee

Study Results

No Results Posted as of Nov 15, 2013