Osteoarthritis Clinical Trial
Official title:
A Single Center, Randomized, Double-blind, Placebo-controlled 2-way Crossover Study to Investigate the Mechanism of Action of Etoricoxib in Subjects With Osteoarthritis Knee Pain.
The purpose of this study is to investigate which pain mechanisms that can be affected by etoricoxib compared to placebo (inactive medication)in subjects with painful knee osteoarthritis af 4 weeks of treatment.
Study Rationale: The purpose of this study is to investigate which pain mechanisms in
subjects with painful knee osteoarthritis can be affected by the peripheral and central
actions of etoricoxib as compared to placebo during a 4 week treatment therapy period.
The present study will utilize a set of quantitative mechanism based pain biomarkers to
assess peripheral and central pain manifestations in OA and the influence of etoricoxib on
those individual manifestations in an attempt to understand and explain clinical pain
alleviation.
Study Treatment: Subjects will be randomized to one of the 2 sequences of treatment: Sequence
1 (60 mg/day etoricoxib followed by placebo) or Sequence 2 (placebo followed by 60 mg/day
etoricoxib). The two treatment periods of 4 weeks each are separated by a washout period of
at least 6 days.
Primary Objective: To assess which pain mechanisms are modulated by 60 mg daily
administration of etoricoxib compared to placebo in subjects with osteoarthritic (OA) knee
pain during two treatment periods of 4-weeks each.
Secondary Objectives: To evaluate if changes in any of the mechanism based experimental pain
assessment parameters can explain changes in clinical outcome parameters.
To profile drug responders- versus non-responders based on pain mechanisms involved.
To investigate if change in inflammatory, bone and cartilage related bio-chemical biomarkers
can explain changes in either experimental or clinical pain parameters.
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