Clinical studies
Celebrex™ has demonstrated significant
reduction in joint pain secondary to osteoarthritis (OA) compared to
a placebo. Celebrex™ was evaluated for treatment of the signs
and the symptoms of OA of the knee and hip in approximately 4,200 patients
in placebo- and active-controlled clinical trials of up to 12 weeks
duration. In patients with OA, treatment with Celebrex™ 100 mg
twice per day or 200 mg once per day resulted in improvement in WOMAC
(Western Ontario and McMaster Universities) osteoarthritis index, a
composite of pain, stiffness, and functional measures in OA. In three
12-week studies of pain accompanying OA flare, Celebrex™ doses
of 100 mg twice per day and 200 mg twice per day provided significant
reduction of pain within 24-48 hours of initiation of dosing. At doses
of 100 mg twice per day or 200 mg twice per day the effectiveness of
Celebrex™ was shown to be similar to that of naproxen 500 mg BID.
Doses of 200 mg twice per day provided no additional benefit above that
seen with 100 mg twice per day. A total daily dose of 200 mg has been
shown to be equally effective whether administered as 100 mg twice per
day or 200 mg once per day.
Celebrex™ has demonstrated significant
reduction in joint tenderness/pain and joint swelling in Rheumatoid
Arthritis compared to placebo. Celebrex™ was evaluated for treatment
of the signs and symptoms of RA in approximately 2,100 patients in placebo-
and active-controlled clinical trials of up to 24 weeks in duration.
Celebrex™ was shown to be superior to placebo in these studies,
using the ACR20 Responder Index, a composite of clinical, laboratory,
and functional measures in RA. Celebrex™ doses of 100 mg twice
per day and 200 mg twice per day were similar in effectiveness and both
were comparable to naproxen 500 mg twice per day.
Although Celebrex™ 100 mg twice per
day and 200 mg twice per day provided similar overall effectiveness,
some patients derived additional benefit from the 200 mg twice per day
dose. Doses of 400-mg day provided no additional benefit above that
seen with 100-200 mg twice per day.
