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News EULAR Auj. à 19:53
THU0341
A RANDOMIZED, PARALLEL GROUP, DOUBLE BLIND, PLACEBO AND NAPROXEN
CONTROLLED, MULTICENTER PHASE 3 STUDY OF NAPROXCINOD IN SUBJECTS WITH
OSTEOARTHRITIS OF THE KNEE: EFFICACY RESULTS FOLLOWING 13-WEEK TREATMENTC. E. Marrero1, C. Tuten2, T. Shamin3, V. Awasty4, J. Agaiby5, D. Hassman6, J. Sutphen7, H. Frayssinet8, B. Duquesroix*8
1Medicine, Deep South Clinical Research, Nederland, 2Medicine, Clinical Center of Asheville, Asheville, 3Medicine, Heartland Clinical Research, Omaha, 4Internal Medicine, R & R Research, Marion, 5Medicine, Clinical Investigation Specialist Inc, Gurnee, 6Medicine, Comprehensive Clinical Research, Berlin, 7Research and Development, NicOx Inc, Warren, United States, 8Research and Development, NicOx SA, Sophia Antipolis, France
Background:
Naproxcinod is a Cycloxygenase Inhibiting Nitric Oxide Donator (CINOD)
under development for the relief of signs and symptoms of OA. In
previous trials naproxcinod has shown anti-inflammatory and analgesic
properties similar to traditional NSAIDs and COX2 inhibitors associated
with a favorable safety and tolerability profile.
Objectives:
The primary objective of the study was to show that naproxcinod 375 mg
bid and 750 mg bid were superior to placebo in relieving signs and
symptoms in subjects with OA of the knee at Week 13.
Methods:
Subjects (40+ years of age) meeting ACR criteria for knee OA and
experiencing a flare of pain at baseline after discontinuation of
previous analgesic treatment were randomized (1:1:1:1) to either
naproxcinod 375 mg or 750 mg bid, naproxen 500 mg bid or placebo bid.
The three co-primary efficacy variables were the mean change from
Baseline to Week 13 in WOMAC™ pain and function subscale scores and
subject’s global assessment of disease status to compare naproxcinod
with placebo for superiority.
The analysis of each primary
efficacy variable was based on an analysis of covariance (ANCOVA) model
with treatment group and center as factors, and baseline value as
covariate. The primary efficacy analysis was performed using the
Intent-to-Treat (ITT) population and was performed on as-randomized
basis.
Results:
The ITT population consisted of 1011 subjects from 129 centers in the
US. 71.0% of subjects were female, 78.9% Caucasian; mean age was 59.8
years, mean BMI 33.8 kg/m2. At Week 13, 766 subjects completed the
study (75.8%).
Both doses of naproxcinod (375 mg bid and 750 mg
bid) demonstrated superior efficacy to placebo in the three co-primary
endpoints of WOMAC™ pain and function, and subject’s overall rating of
disease status (pPercent
of subjects with at least 1 AE was 47.0%, 46.4%, for naproxcinod 375
and 750 mg bid, respectively, 47.7% for naproxen and 44.8% for placebo.
Conclusion:
This study demonstrated the clinical efficacy of both naproxcinod doses
over placebo, confirming the results of previous trials. Treatments
were safe and well tolerated.
References: Study HCT 3012-X-302. First 13 weeks of treatment.
Disclosure of Interest: CEM, CT, TS, VA, JA, DH were investigators in this NicOx' sponsored study.
JS, HF, DB are Nicox' employees.