Ambulatory arthroscopic knee surgery
Conditions
Interventions
Trade Name: Prexige 400 mg film-coated tablets
Product Name: Prexige
Product Code: COX189
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lumiracoxib
CAS Number: 220991-20-8
Current Spons
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The following patients may be included in the trial: 1. Who have signed a written informed consent before any study procedure is performed. 2. Male or female outpatients of at least 18 years of age. 3. Who need scheduled minor ambulatory arthroscopic knee surgery, with the exclusion of diagnostic arthroscopy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following patients will be excluded from the trial: 1. Who are pregnant or lactating. Female patients of child-bearing potential must use a reliable method of contraception throughout the study 2. With known hypersensitivity to any of the study drugs (including analgesics, antipyretics, narcotics, or NSAIDs or any cox-2 inhibitors) or to drugs with similar chemical structures. 3. Who have experienced, any time in the past, allergic-type reaction after taking acetylsalicylic acid (ASA)/ aspirin or NSAIDs, including but not limited to history of: asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria, etc. 4. With evidence of cardiovascular disorder: congestive heart failure (NYHA class II – IV), established ischemic heart disease, peripheral arterial disease or cerebrovascular disease; cardiac dysfunction, cardiac failure or left ventricular dysfunction. 5. With evidence of hepatic or gastrointestinal disorder: severe hepatic disease (Child-Pugh >9), history of drug or alcohol abuse within the last 2 years; disease of gall bladder and pancreas; active peptic ulceration within the previous 12 months, gastrointestinal bleeding within the last 5 years (except history of minor lower gastro-intestinal tract bleeding, such as from hemorrhoids or anal fissures) or history of gastro-esophageal reflux disease or hiatus hernia; inflammatory bowel disease. 6. With evidence of renal disorder: (estimated creatinine clearance <30 ml/min) or patients with impaired renal function, pre-existing edema or severely dehydrated patient. 7. Who have been treated with other investigational drugs at the time of enrollment, or within 30 days or 10 half-lives prior to screening, whichever is longer. 8. Who are taking anticoagulants (e.g. warfarin, low-molecular weight heparin) and anti-platelet aggregation agents (except low-dose aspirin 75 mg – 100 mg/ day for cardioprotection). 9. With any surgical or medical conditions which, at the discretion of the investigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirements of the study or completing the trial period. 10. With a history of noncompliance to medical regimens and patients who are considered potentially unreliable. 11. Who are engaged in disease-related litigation. 12. Who have already been randomized to this study for one knee. 13. With known reduced CYP2C9 activity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Pain intensity in the target knee after movement at the 2 hour time-point based on the VAS (visual analog scale);Main Objective: The primary objective of this trial is to demonstrate superior efficacy of preemptive dosing with lumiracoxib 400 mg compared to post-operative dosing with lumiracoxib 400 mg in reducing pain intensity (PI) in the target knee after movement at the 2 hour time-point, using a 0-100 mm Visual Analog Scale (VAS), in patients who have had ambulatory arthroscopic knee surgery.;Secondary Objective: Secondary objectives of this study are to assess in patients who have had ambulatory artroscopic knee surgery, the efficacy of preemptive dosing with lumiracoxib compared to post-operative dosing with respect to: • PI on a 0-100 mm VAS at 1, 2, 3, 4 and 24 hour time-points while at rest, • PI on a 0-100 mm VAS at 1, 3, 4 and 24 hour time-points after movement, • time to first rescue medication intake, • the patient’s global evaluation of response to study medication, and to assess the safety and tolerability profile of lumiracoxib. | — |
Countries
Germany
Outcome results
None listed