N/A
Completed N=579
Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency
Source: ClinicalTrials.gov NCT01427725 ↗Enrolled (actual)
579
Serious AEs
14.6%
Results posted
Jun 2022
Primary outcomePrimary: Number of Patients With Adverse Drug Reaction — 36 participants
Summary
This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with LipaCreon for a long term in order to evaluate the effective and safe use of LipaCreon.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Drug Reaction |
36 | — |
| SECONDARY Degree of General Improvement |
240; 62; 1; 11 | — |
| SECONDARY Nutritional Endpoints - BMI |
20.452; 20.193; 20.229; 20.520; 20.720 | — |
| SECONDARY Nutritional Endpoints - Serum Total Protein |
6.579; 6.955; 6.761; 6.901; 6.914 | — |
| SECONDARY Nutrition Endpoints - Albumin |
3.688; 3.912; 3.843; 3.984; 3.959 | — |
| SECONDARY Nutrition Endpoints - Total Cholesterol |
164.32; 169.40; 169.77; 168.88; 169.41 | — |
| SECONDARY Patient's Quality of Life - Physical Health (Summary) |
42.057; 46.086; 47.919; 48.985 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea |
84; 386; 33; 330; 22; 333 | — |
| SECONDARY Nutrition Endpoints - Triglycerides |
123.5; 128.8; 118.6; 117.9; 126.5 | — |
| SECONDARY Nutrition Endpoints - Haemoglobin |
12.18; 12.03; 12.12; 12.40; 12.58 | — |
| SECONDARY Patient's Quality of Life - Mental Health (Summary) |
44.619; 47.864; 49.288; 49.894 | — |
| SECONDARY Patient's Quality of Life - General Health |
43.673; 48.238; 50.250; 51.479 | — |
| SECONDARY Patient's Quality of Life - Physical Functioning |
41.941; 45.630; 47.438; 48.325 | — |
| SECONDARY Patient's Quality of Life - Role Physical |
41.325; 45.253; 47.371; 48.222 | — |
| SECONDARY Patient's Quality of Life - Body Pain |
48.282; 52.407; 53.746; 54.594 | — |
| SECONDARY Patient's Quality of Life - Vitality |
44.425; 48.408; 50.263; 51.463 | — |
| SECONDARY Patient's Quality of Life - Social Functioning |
42.345; 46.073; 47.749; 48.633 | — |
| SECONDARY Patient's Quality of Life - Mental Health |
46.066; 49.619; 51.326; 51.745 | — |
| SECONDARY Patient's Quality of Life - Role Emotional |
43.320; 47.179; 48.670; 49.607 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements |
2.37; 1.82; 1.77; 1.51; 1.43 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea |
187; 296; 81; 295; 72; 293 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour |
83; 377; 37; 323; 30; 320 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Decreased Appetite |
169; 313; 72; 304; 58; 304 | — |
| SECONDARY Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension |
130; 345; 42; 330; 37; 322 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency
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 (NCT01427725). 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.