N/A
N=24
Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis
Cystic Fibrosis · Exocrine Pancreatic Insufficiency · Pancreatic Diseases · Digestive System Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01427712 ↗Enrolled (actual)
24
Serious AEs
19.1%
Results posted
Jun 2022
Primary outcome: Primary: Number of Patients With Adverse Drug Reaction — 1 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Pancrelipase (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Mylan Inc.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Drug Reaction |
1 | — |
| SECONDARY Nutritional Endpoints - BMI |
15.093; 15.583; 15.649; 15.604; 15.698; 15.766 | — |
| SECONDARY Nutritional Endpoints - Serum Total Protein |
7.282; 6.925; 6.700; 7.350; 7.421; 7.563 | — |
| SECONDARY Nutrition Endpoints - Albumin |
3.872; 4.054; 4.067; 4.130; 4.232; 4.390 | — |
| SECONDARY Nutrition Endpoints - Total Cholesterol |
124.94; 126.10; 128.00; 139.13; 123.11; 148.17 | — |
| SECONDARY Nutrition Endpoints - Triglycerides |
81.6; 126.1; 73.2; 80.5; 117.1; 83.6 | — |
| SECONDARY Nutrition Endpoints - Haemoglobin |
12.02; 12.38; 12.07; 12.82; 12.89; 13.41 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea |
14; 4; 4; 8; 2; 7 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements |
2.40; 1.90; 1.86; 1.83; 1.82; 1.75 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea |
6; 13; 1; 12; 0; 10 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour |
6; 13; 1; 12; 2; 8 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Inappetence |
7; 13; 0; 13; 0; 10 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension |
5; 15; 1; 12; 2; 8 | — |
| SECONDARY Degree of General Improvement |
9; 5; 0; 0 | — |
| SECONDARY Degree of General Improvement |
9; 5; 0; 0 | — |
Summary
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.
Eligibility Criteria
Inclusion Criteria
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis
Exclusion Criteria
- Patients with a history of hypersensitivity to the ingredient of LipaCreon.
- Patients with a history of hypersensitivity to porcine protein
Data sourced from ClinicalTrials.gov (NCT01427712). 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.