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Knee OsteoarthritisPhase 4NCT01985165

A Phase 4 Study of Imrecoxib in Treatment of Knee Osteoarthritis

A Phase 4 study testing Imrecoxib in people with Knee Osteoarthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 19 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Imrecoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,400 participants
Where
19 sitesChina
Study dates
May 2013to Nov 2013
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

China19 sites

  • BeijingChao-YangHospital

    Beijing, 100020

  • China-Japan Friendship Hospital

    Beijing, 100029

  • Peking University First Hospital

    Beijing, 100034

  • Beijing Hospital of the Ministry of Health

    Beijing, 100730

  • Peking Union Medical College Hospita

    Beijing

  • Peking University Third Hospital

    Beijing

  • Cangzhou Central Hospital

    Cangzhou, Hebei

  • Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    Chongqing, 400042

  • The Second Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Qianfoshan Hospital Affiliated to Shandong University

    Jinan, Shandong, 250014

  • The Second Hospital of Shangdong University

    Jinan, Shandong

  • The First People's Hospital of Lianyungang

    Lianyungang, Jiangsu, 222002

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Taizhou Hospital

    Taizhou, Zhejiang

  • Tianjin First Center Hospital

    Tianjin

  • Tongji Hospital

    Wuhan, Hubei, 430030

Other trials in China

About this study

Official title: A Multicenter，Open-label Phase Ⅳ Trial of Imrecoxib in Treatment of Knee Osteoarthritis

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

Being tested
Imrecoxib
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImrecoxibDrug

Study groups in NCT01985165
Study groupRoleWhat they receive
ImrecoxibExperimental0.1g,BID,po
Receives: Drug: Imrecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Patient's Assessment of Arthritis Pain, according to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)3.0

    Measured: Baseline to Week 24

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Baseline to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionNov 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01985165
Sponsor's protocol ID
HRARXB00434
Status last verified
Nov 2013
First submitted
1 Nov 2013
Last updated
15 Nov 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Imrecoxib in people with Knee Osteoarthritis, run by Jiangsu HengRui Medicine Co., Ltd. at 19 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01985165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.

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