A Phase 3 interventional study of Pregabalin, Celecoxib in Osteoarthritis, sponsored by Sunnybrook Health Sciences Centre. Completed. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-11.
Sponsored by Sunnybrook Health Sciences Centre · Phase 3, Interventional, and Treatment
Despite the development of new pain medications, the prevalence of persistent postoperative pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced function after surgery are of great concern since they have a significant impact on a patient's quality of life and are costly to society in terms of longer hospital stays and lost work days. An important risk factor for chronic pain and reduced function after surgery is the amount of pain patients experience immediately after surgery which is highly influenced by the amount of pain patients have preoperatively. For many patients, longstanding pain prior to surgery is common and thus can compromise the outcome of the procedure. Therefore, the aim of this study is to reduce the amount of pain patients have before they undergo surgery by administering a novel pain-relieving regimen in the weeks before surgery. Crucially, this treatment will be continued for three weeks after surgery to reduce pain that arises from the surgical trauma. The novel regimen will include a non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This drug combination will provide the best opportunity to target several key sites in the pain pathway. This regimen will be tested in patients with pain related to osteoarthritis and who are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these patients and is the main reason for undergoing surgery. The goal of this research proposal is to adequately manage pain before and after surgery in order to improve function weeks after surgery. If controlling pain in this way does lead to improved long term postoperative function the findings from this study may lead to the development of a standardized regimen. This is highly relevant not only for orthopedic procedures but following other common surgical procedures which would be of great benefit to patients and the entire healthcare system.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Sunnybrook Health Sciences Centre is the lead sponsor of 566 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Prospective, single center, randomized, double-blinded, placebo controlled study
Drug: Pregabalin, Celecoxib
Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.
Physical function
Time frame: 6 weeks postop
Pain
Time frame: Pre and postoperatively (up to 6 weeks)
No study locations are listed for this record.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Sunnybrook Health Sciences Centre