Phase 3
Completed N=32
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Source: ClinicalTrials.gov NCT00510484 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcomePrimary: Coefficient of Fat Absorption (%) — 88.62; 49.78 Percentage — p=<0.001
Summary
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coefficient of Fat Absorption (%) |
88.62; 49.78 | <0.001 sig |
| SECONDARY Coefficient of Nitrogen Absorption (%) |
85.06; 49.99 | <0.001 sig |
| SECONDARY Total Fat Excretion (Grams) |
57.7; 243.2 | <0.001 sig |
| SECONDARY Total Stool Weight (Grams) |
630.1; 1582.5 | <0.001 sig |
| SECONDARY Stool Frequency |
1.75; 2.88 | <0.001 sig |
| SECONDARY Percentage of Days With no Flatulence. |
41.6; 23.1 | 0.013 sig |
| SECONDARY Percentage of Days With no Abdominal Pain. |
90.3; 59.1 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Confirmed PEI by historical CFA < 70% without supplementation or current or historical fecal elastase < 50µg/g stool (within the last 12 months)
- Subjects of 12 years or older
- Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months
- Clinically stable condition without evidence of acute respiratory disease or any other acute condition
- Females of child-bearing potential must agree to continue using a medically acceptable method of birth control
Exclusion Criteria
- Ileus or acute abdomen
- History of fibrosing colonopathy
- History of distal ileal obstruction syndrome within 6 months of enrollment
- Use of an immunosuppressive drug
- Any type of malignancy involving the digestive tract in the last 5 years
- Known infection with HIV
Data sourced from ClinicalTrials.gov (NCT00510484). 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.