Phase 3
Completed N=40
Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency
Pancreatic Exocrine Insufficiency
Source: ClinicalTrials.gov NCT01747330 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Body Weight — 0.75 kg
Summary
The purpose of this study is to evaluate the safety and tolerability of Creon micro in children younger than four years with pancreatic exocrine insufficiency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight |
0.75 | — |
| PRIMARY Height |
0.026 | — |
| PRIMARY Stool Frequency |
2.1 | — |
| PRIMARY Stool Consistency |
55.4 | — |
| PRIMARY Subject's Acceptance of Treatment |
37.5; 52.5; 10.0; 0 | — |
| SECONDARY Number of Subjects With Adverse Events |
16 | — |
| SECONDARY Pulse |
-3.1 | — |
| SECONDARY Number of Participants With Findings During Physical Examination |
12 | — |
| SECONDARY Number of Participants With Clinical Relevant Safety Laboratory Values |
— | — |
Eligibility Criteria
Inclusion Criteria
- Children younger than four years with confirmed cystic fibrosis diagnosis and a body weight of at least 2 kilograms
Exclusion Criteria
- Ileus or acute abdomen
- history of fibrosing colonopathy
- history of distal ileal obstruction without surgery
- solid organ transplant or surgery affecting the large bowel, other than appendectomy
Data sourced from ClinicalTrials.gov (NCT01747330). 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.