Cystic fibrosis MedDRA version: 17.1 Level: LLT Classification code 10011765 Term: Cystic fibrosis pancreas System Organ Class: 100000004850
Conditions
Interventions
Trade Name: PANCREASE MT
Product Name: PANCREASE MT
Pharmaceutical Form: Capsule
INN or Proposed INN: pancrelipase
Other descriptive name: PANCRELIPASE AMYLASE
Concentration unit: Other
Concentration
Sponsors
Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: Not applicable;Primary end point(s): Change in the coefficient of fat absorption (COA-fat percent);Timepoint(s) of evaluation of this end point: 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change in Percent COA-Protein (Nitrogen) - Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase;Timepoint(s) of evaluation of this end point: - 72-hours stool collection in the open-label phase to the end of 72-hours stool collection in the double-blind withdrawal phase. - Entire 7 days double-blind phase | — |
Countries
Canada, United States
Contacts
Public ContactClinical Registry Group-JB BV
Janssen Research and Development
Outcome results
None listed