A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004004-12-BG
• Date of registration: 05/02/2008
• Prospective Registration: Yes
• Primary sponsor: Solvay Pharmaceuticals GmbH
• Public title: A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
• Scientific title: A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
• Date of first enrolment: 28/02/2008
• Target sample size: 52
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004004-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: 7 days double-blind, placebo-controlled treatment followed by 6 months of open-label treatment If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Bulgaria

Key inclusion & exclusion criteria

Inclusion criteria:
•Signed Informed Consent

•Age = 18 years

•Chronic pancreatitis or pancreatectomy (total or partial)
- Chronic Pancreatitis must be proven (in medical history) by at least one of the following criteria:
- Imaging techniques (ultrasound, CT, MRI, or endoscopic ultrasound)
- ERCP (endoscopic retrograde cholangiopancreatography)
- Plain film of the abdomen with pancreatic calcification
- Histology
- Pancreatectomy must have occurred more than 180 days prior to enrollment

•Pancreatic exocrine insufficiency has to be proven (in medical history) by either:
- pathological direct or indirect pancreatic function tests
or
- clinical signs of severe steatorrhea, e.g. loose bulky stools or visible stool fat, that resolved upon administration of pancreatic enzyme supplementation
or
- total pancreatectomy

•Females of child-bearing potential must agree to continue using a medically acceptable method of birth control or agree to abstain from sexual intercourse (abstinence option only with agreement from the local IRB) throughout the study and for thirty days immediately after the last dose of study drug. Medically acceptable methods of birth control are defined as either a bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (Depo-Provera?), an intrauterine device (IUD), or an oral contraceptive that has been taken for at least three months, which the subject agrees to continue using during the study, or a double-barrier method which must consist of a combination of any two of following: diaphragm, cervical cap, condom, or spermicide.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic (except underlying disease), hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/ connective tissue, musculoskeletal, metabolic/nutritional (except underlying disease), endocrine (except diabetes mellitus), neurologic / psychiatric, allergy, recent major surgery (excluding appendectomy and pancreatectomy for CP or abdominal surgery due to underlying disease or gall bladder removal), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which, might limit participation in or completion of the study.

- Ileus or acute abdomen
- Pregnant or lactating females.
- Any type of malignancy involving the digestive tract in the last 5 years except pancreatic cancer
- Any type of malignancy not in remission
- Celiac disease, isolated gastrectomy, Crohn´s disease and small bowel surgery
- Presence of pseudo-pancreatic cyst = 4 cm
- Continued excessive intake of alcohol or drug abuse
- Known allergy to pancreatin or inactive ingredients of Creon
- Suspected non-compliance or non-cooperation
- Intake of experimental drug within 4 weeks prior to study start
- Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject’s participation in or to complete the study.
- Known infection with HIV.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1 Level: LLT Classification code 10009093 Term: Chronic pancreatitis
MedDRA version: 9.1 Level: LLT Classification code 10033596 Term: Pancreatectomy

Intervention(s)

Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Pharmaceutical Form: Capsule, hard
Other descriptive name: Pancrelipase/Pancreas Powder
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 12000-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Pharmaceutical Form: Capsule, hard
Other descriptive name: Pancrelipase/Pancreas Powder
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 24000-

Primary Outcome(s)

Secondary Objective: To investigate the effect of pancrelipase delayed release capsules on CNA (coefficient of nitrogen absorption), stool fat, stool weight, nutritional parameters (triglycerides, LDL cholesterol, HDL cholesterol, retinol-binding proteins, pre-albumin, cholesterol), clinical symptomatology (stool frequency, stool consistency, abdominal pain, flatulence, appetite), Quality of life (QoL) using the SF-36, Body Mass Index (BMI).

Main Objective: The primary objective is to compare the change in CFA of the placebo and pancrelipase groups from baseline (during the single-blind, placebo run-in period) to the end of the randomized, double blind treatment period.

Primary end point(s): Efficacy:
The primary efficacy parameter will be the change in CFA from baseline to the end of double blind treatment.

Safety:
The safety and tolerability data collected during this study include vital signs, safety laboratory values and adverse events.

Secondary ID(s)

S245.3.124