RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A GASTRO-RESISTANT FILM-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 002
- Conditions
- The purpose of this trial is to evaluate the clinical efficacy and safety of a gastro-resistant film-coated tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitisMedDRA version: 7.0Level: LLTClassification code 10033628
- Registration Number
- EUCTR2005-000562-38-DE
- Lead Sponsor
- Berlin-Chemie AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Patients must meet ALL of the following criteria:
1. Male or female, Caucasian, aged 18-75 years.
A female of childbearing potential may be enrolled, pro-vided she has a negative pregnancy test at Screening and is routinely using adequate contraception prior to and during the trial and agrees not to attempt to become pregnant during the trial.
A female of non-childbearing potential will be defined as one who has been postmenopausal for at least one year or has been surgically sterilised at least three months prior to the start of the trial or had a hysterectomy.
2. Chronic pancreatitis documented by a score of 4 or more added-up using the following scoring system (modified ac-cording to Layer et al. (1994)):
- 4, pancreatic calcification documented by any imaging procedure;
- 4, typical histological changes;
- 3, characteristic findings on endoscopic retrograde cholangiopancreatography (ERCP) or endosonography;
- 2, pancreatic exocrine insufficiency (steatorrhoea by abnormal qualitative or quantitative faecal fat excretion > 7 g/day or abnormal direct function test result (secre-tin-pancreozymin or cholecystokinin test) or pancreo-lauryltest = 20% or faecal elastase 1 test result < 100 µg/g; the result of the latter two tests may be ob-tained during the Screening Phase);
- 2, attacks of acute pancreatitis in the anamnesis and/or upper abdominal pain;
- 1, diabetes mellitus (disturbed glucose tolerance re-quiring continuous control by diet alone or with the ad-dition of oral agents or insulin)
3. Faecal elastase 1 test result < 100 µg/g faeces at Screening.
4. Patients with chronic pancreatitis due to alcohol abuse may be included provided they show no clinical symptoms of recent alcohol consumption and no alcohol withdrawal symptoms.
5. Patients who, after the nature of the trial and the disclosure of their data has been explained to them, have freely given their Informed Consent in writing.
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) yes
F.1.3.1 Number of subjects for this age range
Patients will be excluded for ANY ONE of the following reasons:
1. Patients with acute pancreatitis or with an acute attack of chronic pancreatitis at Screening or within the last two weeks before Screening.
2. Resection of the head of the pancreas or gastric resection or any operation which destroyed the physiological gastrointestinal junction, e.g. operation according to Y-Roux, Billroth II, Whipple
3. Any obstructive disease of the biliary tract (e.g. obstructive icterus)
4. Any malignant tumour, e.g. pancreatic carcinoma or recurrence of a malignant tumour within the last 5 years
5. Other causes for exocrine pancreatic insufficiency than chronic pancreatitis, e.g. cystic fibrosis, primary sclerosing cholangitis, haemochromatosis, isolated enzyme deficiency, deficiency in activation of enzymes in the small intestine
6. Inflammatory disease of the intestine
7. History of strictures in the gastrointestinal tract
8. Peptic ulcer or gastrointestinal bleeding within the last 12 months
9. Patients with ASAT/SGOT and/or ALAT/SGPT greater than three times the upper limit of the laboratory reference range or any clinically significant laboratory abnormality that in the opinion of the investigator would interfere with the conduct of the study.
10. Bilirubin = 34 µmol/l
11. Albumin = 35 g/l
12. INR = 1.7
13. Patients with a history or clinical evidence of any relevant cardiac, cardio- or cerebrovascular, renal, pulmonary, endocrine, neurologic, infectious, other gastrointestinal, haematological, oncological or psychiatric disease or emotional problems, which, in the opinion of the investigator, would pose a significant risk for the patient, invalidate the giving of Informed Consent or limit the ability of the patients to comply with study requirements or interfere otherwise with the conduct of the study. The same applies for immunocompromised patients and/or neutropenic patients.
Patients with a known hypersensitivity and/or contraindication to pork or porcine pancreatin or other components of the study medication or other cross-allergies.
14. Patients unwilling or unable to tolerate discontinuation of their previous pancreatic enzyme substitution.
15. Patients who have donated 450 mL or more blood during the last three months before Screening.
16. Patients who have received an investigational drug within 30 days prior to entering the active treatment phase.
17. Patients who are unwilling or unable to provide Informed Consent or to participate satisfactorily for the entire trial period.
18. Patients taken into custody by court or authorities.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method