A Phase III, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of MK 0663/Etoricoxib in Patients with Rheumatoid Arthritis

Not Applicable

• Conditions: -M05-M06; M05

• Registration Number: PER-020-13
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 39

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified