Phase 3
N=32
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00510484 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Coefficient of Fat Absorption (%) — 88.62; 49.78 Percentage — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pancrelipase Delayed Release (Drug); Placebo Comparator (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Solvay Pharmaceuticals
- Primary completion
- Mar 2008
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 |
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.
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.