Cystic Fibrosis Clinical Trial
Official title:
A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 7 Years to 60 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the Coefficient of Fat Absorption (COA-fat Percent) | Change in the coefficient of fat absorption (percent COA-fat) from the 72-hour inpatient period in the open-label phase to the 72-hour period inpatient period in the double-blind (withdrawal) phase. | 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | No |
Secondary | Change in Percent COA-Protein (Nitrogen) | The change in percent COA-protein from the stool collection period in double-blind phase to open-label phase | 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | No |
Secondary | Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase | Percent of patients reporting nausea, vomiting, bloating, diarrhea, oily/greasy stools, and abdominal pain signs and symptoms reported as Adverse events during the double-blind phase. | Entire 7 days double-blind phase | No |
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