Patients remain on their drug regimen for 48 weeks. Patients remain on their drug regimen for 48 weeks. Phase Phase II A phase two trial follows phase one. It consists of a larger, randomized sample of patients. The purpose of a phase two trial is to see if the drug is effective at doing what the manufacturer claims it should do.
Researchers also watch closely for unexpected adverse reactions.
At least 48 weeks. At least 48 weeks. Availability for at least 48 weeks of follow-up. Intractable diarrhea within 30 days prior to study entry. History of acute or chronic pancreatitis.