A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency

Completed · Phase 3 · Has a placebo group

Conditions studied: Exocrine Pancreatic Insufficiency, Steatorrhea, Malabsorption Syndromes, Cystic Fibrosis

In brief

The purpose of this study is to assess the effectiveness and safety of oral pancrelipase MT in the treatment of adult and pediatric/adolescent cystic fibrosis (CF) patients with clinical symptoms of exocrine pancreatic insufficiency (EPI).

Key facts

Study ID

NCT00662675

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

40

Starts

2008-08-01

Expected to finish

2009-02-01

Last updated by the study team

2014-05-09

Who can join

Age: 7 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have a diagnosis of CF documented by sweat chloride results (>60 mmol/L) and require pancreatic enzyme replacement therapy (PERT) to control clinical symptoms of EPI (nausea, vomiting, bloating, diarrhea, and abdominal pain) with a history of excess fat in the feces
• Have documentation of an abnormal COA-fat and a fecal elastase result of <100 micrograms fecal elastase/gram stool
• Must be on a stable diet and dose of pancreatic enzyme supplementation that has provided satisfactory symptom control for at least the past 1 month

You may not qualify if…

• No extreme physical wasting with loss of weight and muscle mass
• No severe, acute, or chronic pulmonary disease unrelated to complications of CF
• No worsening of pulmonary disease in past 30 days
• No use of drugs known to affect blood uric acid concentrations (e.g., aspirin, diflunisal, allopurinol, probenecid, thiazide diuretics, phenylbutazone, sulfinpyrazone)
• No known congenital (present at birth) abnormalities of the gastrointestinal tract, heart, or liver
• No distal intestinal obstruction syndrome (DIOS)

Where it is running

• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Orlando, Florida, United States
• Study site — Louisville, Kentucky, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Long Branch, New Jersey, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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