Phase 3
Completed N=40
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
Exocrine Pancreatic Insufficiency · Steatorrhea · Malabsorption Syndromes · Cystic fibrosis
Source: ClinicalTrials.gov NCT00662675 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcomePrimary: Change in the Coefficient of Fat Absorption (COA-fat Percent) — -34.1; -1.5 percentage COA-fat — p=<0.001
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 exocrine pancreatic insufficiency (EPI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Coefficient of Fat Absorption (COA-fat Percent) |
-34.1; -1.5 | <0.001 sig |
| SECONDARY Change in Percent COA-Protein (Nitrogen) |
-26.5; 1.3 | <0.001 sig |
| SECONDARY Percent of Patients Reporting Clinical Signs and Symptoms of Exocrine Pancreatic Insufficiency (EPI) During the Double-Blind Phase |
55; 20; 30; 15; 15; 5 | — |
Eligibility 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 <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)
Data sourced from ClinicalTrials.gov (NCT00662675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.