Status:
COMPLETED
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Exocrine Pancreatic Insufficiency
Steatorrhea
Eligibility:
All Genders
7-60 years
Phase:
PHASE3
Brief Summary
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 e...
Detailed Description
This is a randomized, placebo-controlled, double-blind withdrawal, multicenter study to evaluate the effectiveness of pancrelipase MT capsules compared with placebo in the treatment of adult (\>18 to ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00662675
Start Date
August 1 2008
End Date
February 1 2009
Last Update
May 9 2014
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Long Beach, California, United States
2
Los Angeles, California, United States
3
Orlando, Florida, United States
4
Louisville, Kentucky, United States