Pfizer backs $100 million study of Celebrex
The 200,000 patient clinical trial, to be launched by The Cleveland Clinic, is set to begin next year and will compare Celebrex and prescription doses of the popular OTC tablets ibuprofen and naproxen, sold under the brand names Advil and Aleve.
To lead the study, Pfizer has turned to an early critic of COX-2 painkillers, Dr. Steven Nissen, a cardiologist at the Cleveland Clinic.
"The public and the medical community are confused," Nissen told The Wall Street Journal. "The relative safety of these three drugs is simply not known. We're going to have to answer the question are they the same or not."
In a story in today's New York Times, Nissen said the study was a big gamble for Pfizer. "This could show that celecoxib is the best drug or the worst drug," he said.
Study participants will be randomly assigned to one of the three drugs: neither they nor their doctors will know which one. They will take low-dose aspirin and other medicine, such as cholesterol–lowering statins, according to guidelines for people at risk of heart disease. They will take Prilosec to help prevent ulcers and stomach bleeding, a common side effect of nonsteroidal anti-inflammatory drugs (NSAIDs).
"...Clearly this is an important question and a very important patient population that the study is going to look at," a Pfizer spokeswoman told The New York Times.
Worldwide sales of Celebrex, the only remaining COX-2 drug marketed in the U.S., have declined 45% since last year, but the drug still had a revenue of approximately $1.3 billion in the first nine months of 2005, company figures show.