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One week double-blind, randomized, placebo-controlled, parallel-group, multi-center study with Creon® 25000 Minimicrospheres™ in subjects with pancreatic exocrine insufficiency after pancreatic surgery, followed by an open-label long-term extension of 1 year

One week double-blind, randomized, placebo-controlled, parallel-group, multi-center study with Creon® 25000 Minimicrospheres™ in subjects with pancreatic exocrine insufficiency after pancreatic surgery, followed by an open-label long-term extension of 1 year

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004854-29-DE
Enrollment
54
Registered
2007-03-28
Start date
2007-09-21
Completion date
Unknown
Last updated
2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Exocrine Insufficiency MedDRA version: 8.1 Level: PT Classification code 10033628 Term: Pancreatic insufficiency

Interventions

Trade Name: Kreon® 25 000 Product Name: Kreon® 25 000 Pharmaceutical Form: Capsule* Other descriptive name: Pancreatin, Pancreas Powder Ph.Eur. Concentration unit: IU/mg international unit(s)/milligra

Sponsors

Abbott Products GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subject must be = 18 years. 2. Pancreatic exocrine insufficiency after pancreatectomy has to be proven by a CFA value =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate superior efficacy of Creon® 25 000 Minimicrospheres™ over placebo.;Secondary Objective: To investigate the effect of Creon® 25 000 Minimicrospheres™ on CNA (coefficient of nitrogen absorption), stool fat, stool weight, nutritional laboratory parameters (total protein, triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, retinol-binding protein, pre-albumin, albumin, transferrin,), clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence, appetite). Quality of life (QoL) using SF-36® Health Survey, Body Mass Index (BMI) To evaluate the short- and long-term safety and tolerability of Creon® 25 000 Minimicrospheres™, including vital signs, safety laboratory values and adverse events.;Primary end point(s): The change in CFA (coefficient of fat absorption) from baseline (i.e. during the run-in period) to the end of double blind treatment.—

Countries

Bulgaria, Germany, Hungary, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026