Phase 3
N=19
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Cystic Fibrosis · Pancreatic Exocrine Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00775528 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcome: Primary: Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE) — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pancrelipase Delayed Release (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Solvay Pharmaceuticals
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With at Least One Treatment Emergent Adverse Event (TEAE) |
9 | — |
| SECONDARY Stool Fat (% Fat) |
28.11 | — |
| SECONDARY Fat Intake (g) |
46.61 | — |
| SECONDARY Total Calorie Intake (kcal) |
1239.71 | — |
Summary
This study will assess the safety and tolerability of pancrelipase delayed release capsules in subjects up to 6 years of age with Pancreatic Exocrine Insufficiency (PEI) due to Cystic Fibrosis.
Eligibility Criteria
Inclusion Criteria
- Confirmed Cystic Fibrosis (CF) diagnosis by two positive chloride sweat tests or gene analysis
- Current or historical human fecal elastase < 50µg/gstool
- Weight greater than 3.75 kg
- Age 1 month to 6 years
- 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
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 (NCT00775528). 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.