Phase 3
N=17
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
Cystic Fibrosis · Pancreatic Exocrine Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00690820 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: Coefficient of Fat Absorption (%) — 47.41; 82.81 Percentage — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pancrelipase Delayed Release (Drug); Placebo Comparator (Drug)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Solvay Pharmaceuticals
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coefficient of Fat Absorption (%) |
47.41; 82.81 | <0.001 sig |
| SECONDARY Coefficient of Nitrogen Absorption (%) |
44.98; 80.33 | <0.001 sig |
| SECONDARY Total Fat Excretion (Grams) |
182.9; 58.1 | <0.001 sig |
| SECONDARY Total Stool Weight (Grams) |
436.5; 161.4 | <0.001 sig |
| SECONDARY Stool Frequency |
3.46; 1.88 | <0.001 sig |
| SECONDARY Percentage of Days With no Flatulence. |
36.3; 45.0 | 0.671 |
| SECONDARY Percentage of Days With Formed/Normal Stools. |
38.9; 77.7 | 0.003 sig |
| SECONDARY Percentage of Days With no Abdominal Pain. |
65.2; 85.3 | 0.023 sig |
Summary
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.
Eligibility Criteria
Inclusion Criteria
- Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis
- Confirmed PEI by historical Coefficient of fat Absorption < 70% without supplementation or current or historical fecal elastase < 50µg/stool (within the last 12 months)
- 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
- Stable body weight and agrees to abstain from sexual activity
Exclusion Criteria
- Ileus or acute abdomen
- History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome
- 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 (NCT00690820). 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.