None listed
Conditions
Interventions
In Part I and Part II, patients will be allocated to receive
two tablets containing either etoricoxib 90 mg or a
matching placebo and etoricoxib 60 mg or a matching
placebo, once daily. Patie
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients with screening values or findings outside of the normal ranges may, at the discretion of the investigator, have one repeat determination performed and if the repeat value satisfies the criterion they may continue in the screening process. Only the specific out-of-range values should be repeated (not the entire panel). Patients must meet all of the following criteria to participate in the study. 1. Patient is a male or female ≥ 18 years of age on the day of signing informed consent. 2. Patient understands the study procedures, the alternative treatments available, the risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 3. Patient is able to read, understand and complete study questionnaires, including questions requiring a visual analog scale (VAS) response.
Exclusion criteria
Exclusion criteria: • Patients meeting any of the following criteria cannot participate in the study. Previous or Concurrent Diseases ( see page 28 in the clinical protoocol) Previous or Concurrent Medication: (see page 30 in the clinical protocol) Other 18. Patient´s estimated glomerular filtration rate [eGFR: (mL/min/1.73 m2) = 175 x (serum Cr [mg/dL])-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if black)] is ≤ 30 ml/min. 19. Patient has a clinical diagnosis of hepatic insufficiency defined as Child-Pugh score ≥5 (please see Appendix 6.10 for guidance). 20. Patient has new use (within 2 weeks of Visit 1 and during the entire duration of the study and follow-up period) of physical medicine modalities, including but not limited to: physical therapy, chiropractic interventions, acupuncture, Transcutaneous Electrical Nerve Stimulator (TENS), and ultrasound.
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Dominican Republic, Egypt, El Salvador, Finland, France, Germany, Hungary, India, Indonesia, Italy, Korea North, Korea South, Lithuania, Malasya, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Romania, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States, Vietnam
Contacts
Public ContactYngrid Rossana Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed