Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Efficacy and Safety of Postoperative Intravenous Parecoxib Sodium Followed by Oral Celecoxib in Osteoarthritis Patients

Lead Sponsor:

Peking Union Medical College Hospital

Conditions:

Pain

Inflammation

Eligibility:

All Genders

18-90 years

Phase:

PHASE4

Brief Summary

In mainland China, knee Osteoarthritis (OA) is the leading cause of disability in older persons. Total knee arthroplasty (TKA) is now generally regarded by orthopaedic surgeons and patients as an effe...

Detailed Description

Total knee arthroplasty (TKA), though generally regarded as an effective treatment for end-stage knee OA, has been called as "one of the most painful orthopedics surgeries" due to the weight bearing c...

Eligibility Criteria

Inclusion

  • The subject is scheduled to undergo elective unilateral total knee arthroplasty because of OA, performed under a standardized regimen of general anesthesia, as specified in this protocol.
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • The subject is a male or female over 18 years of age.
  • Subjects of childbearing potential must agree to use an effective method of contraception throughout the study and for 42 days after the last dose of assigned treatment.
  • Total duration of the surgical procedure is four hours or less.
  • ASA grade 1-3 subjects.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, standardized rehabilitation scheme, and other study procedures.
  • The subject is in satisfactory health as determined by the investigator on the basis of medical history and physical exam.
  • The subject must demonstrate sufficient psychomotor dexterity and cognitive capacity to use intravenous (IV) patient-controlled analgesia(PCA).
  • The subject who live near to the hospital may be considered prior for the concern of convenient and sufficient follow-up.
  • \-

Exclusion

  • The subject requires a revision to previous knee arthroplasty and/or is having a bilateral knee arthroplasties.
  • The subject requires an emergency knee arthroplasty.
  • Subject uses opioids more than three days/ week prior to operation unless they discontinue the opioids two months prior to screen.
  • Subject has a known hypersensitivity to COX-2 specific inhibitors, sulfonamides, lactose, NSAIDs, opioids or acetaminophen/paracetamol.
  • The subject has a history of arthritis:, chronic pain, metastasis, and Paget's disease.
  • The subject received any investigational medication within 30 days prior to the first dose of study medication.
  • The subject has any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation ≧1.5 times the upper limit of the normal reference range.
  • The subject has an active malignancy of any type, or history of a malignancy (Subjects who have a history of basal cell carcinoma that has been successfully treated can be entered into the study.
  • Subject had any condition, which could preclude use of NSAIDs or COX-2 specific inhibitors.
  • The subject has active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration history.
  • The subject has received warfarin or other anticoagulants during the 30 days preceding the first dose of study medication.
  • Subject is anticipated to require or requires treatment with lithium.
  • Subject is American Society of Anesthesiologists(ASA) grade 4-5.
  • The subject has a history of a psychiatric disorder requiring new or changing treatment
  • The subject has a history of uncontrolled chronic disease or a concurrent clinically significant illness, medical condition.
  • The subject has any cognitive impairment or other characteristics that would in the investigator's opinion preclude study participation or compliance with protocol mandated procedures.
  • Subject has a history of asthma or bronchospasm, which requires treatment with glucocorticoids.
  • Subject had a history of alcohol, analgesic or narcotic abuse.
  • Subject has been previously randomized into the study
  • Subjects who are investigational site staff members or relatives of those site staff
  • Participation in other studies within 3 months before the current study begins and/or during study participation
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation.
  • Pregnant females, breastfeeding females, or males and females of childbearing potential not using effective contraception.
  • \-

Key Trial Info

Start Date :

December 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2016

Estimated Enrollment :

246 Patients enrolled

Trial Details

Trial ID

NCT02198924

Start Date

December 1 2014

End Date

December 1 2016

Last Update

April 19 2019

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Peking Union Medical College Hospital

Beijing, China, 100730