E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with pancreatic exocrine insufficiency (PEI) after pancreatic surgery. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10014698 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate superior efficacy of CREON 25.000 over placebo.The primary efficacy parameter will be the change in Coefficient of fat absorption from baseline to the end of double blind treatment. |
|
E.2.2 | Secondary objectives of the trial |
To investigate the effect of CREON Minimicrospheres on coefficient of nitrogen absorption, stool fat, stool weight, nutritional laboratory parameters, cholesterol, LDL cholesterol, retinol-binding prtein, pre-albumin, albumin, transferrin, vitamin E), clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatuence, appetite), Quality of Life using SF-36 Healthy Survey, Body Mass Index. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Subject must be #8805; 18 years. 2. Pancreatic exocrine insufficiency has to be proven after pancreatectomy by a pancreatic function test: human feacal elastase <50; in medical history or to be done at screening visit. 3. Subjects after pancreatic surgery (partial or total pancreatic resection). 4. Pancreatic surgery was at least 6 months prior to start of the study 5. Subjects in a stable situation after pancreatic surgery; Karnofsky index #8805; 70 6. Subjects with pancreatic resection due to cancer must have finalized adjuvant Chemotherapy 7. Females must be non-lactating and either be of non-childbearing potential (i.e, sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to visit 1 (day -14). |
|
E.4 | Principal exclusion criteria |
1. Unwillingness to participate and/or no signed informed consent 2. Subjects with recurrent tumours 3. Subjects with pancreatic surgery due to acute necrotizing pancreatitis. 4. Investigational drug intake within 30 days prior to the study entry 5. Ileus or acute abdomen 6. Current excessive intake of alcohol or drug abuse 7. Hypersensitivity to porcine proteins / pancreatin |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The change of coefficient of fat absorption (CFA) from baseline to the end of double blind tratment. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |