Statistical Reviewer Briefing Document for the Advisory Committee
نویسنده
چکیده
Rofecoxib was originally submitted as an NDA in November 1998 and approved by the Agency in May 1999 for the relief of sign and symptom of osteo-arthritis (OA) and for the management of acute pain and dysmenorrhea. The current approved maximum dose was 25 mg daily for OA and 50 mg daily for acute pain. The purpose of this supplemental NDA submission was to provide evidence for label revision to remove gastrointestinal (GI) warning section for rofecoxib. A GI outcome study (Protocols 088/089) named VIGOR (Vioxx Gastrointestinal Outcomes Research study) was conducted to support the GI safety claim. The VIGOR trial was a double-blind, randomized, stratified, parallel-group study to compare the occurrence of PUBs (gastroduodenal perforations, gastroduodenal ulcers, or upper gastrointestinal bleeds) between rofecoxib 50 mg daily or naproxen 1000mg per day during chronic treatment for patients with rheumatoid arthritis (RA). This study was divided into two protocols, Protocols 088 and 089. Protocol 088 was a U.S cohort and Protocol 089 an international cohort.
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