RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2005-000736-24-DE
• Date of registration: 13/05/2005
• Prospective Registration: Yes
• Primary sponsor: Berlin-Chemie AG
• Public title: RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003
• Scientific title: RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED PHASE IV TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF AN ENTERIC-COATED PANCREATIN TABLET FOR LIPID DIGESTION AND ABSORPTION IN PATIENTS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE TO CHRONIC PANCREATITIS BY MEANS OF 13C-MIXED TRIGLYCERIDE BREATH TEST - CPI 003
• Date of first enrolment: 14/07/2005
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000736-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
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 dur-ing 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 Screen-ing. In case performance of a valid elastase 1 test is not possible due to diarrhoea (defined as more than three doughy faeces per day or watery faeces) a pancreolauryl test will be performed. The result of the pancreolauryl test must be = 20%.

4. Patients with chronic pancreatitis due to alcohol abuse may be included provided they show no clinical symptoms of re-cent 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

Exclusion criteria:
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.

14. Patients with a known hypersensitivity and/or contraindication to pork or porcine pancreatin or other components of the study medication or other cross-allergies.

15. Patients unwilling or unable to tolerate discontinuation of their previous pancreatic enzyme substitution (see "Other restrictions").

16. Patients who have donated 450 mL or more blood during the last three months before Screening.

17. Patients who have received an investigational drug within 30 days prior to entering the active treatment phase.

18. Patients who are unwilling or unable to provide Informed Consent or to participate satisfactorily for the entire trial period.

19. Patients taken into custody by court or authorities.



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

Health Condition(s) or Problem(s) studied

The purpose of this trial is to evaluate the clinical efficacy and safety of an enteric-coated pancreatin tablet in comparison to placebo in the treatment of pancreatic exocrine insufficiency due to chronic pancreatitis.
MedDRA version: 7.0 Level: LLT Classification code 10033628

Intervention(s)

Trade Name: Helopanflat Mono®
Product Name: Helopanflat Mono®
Product Code: Pancreatin
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Pancreatin
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 10000 IU-lipase
Pharmaceutical form of the placebo: Gastro-resistant tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Primary end point(s): Difference between 13C-exhalation (cumulative percentage of 13C-dose exhaled per hour after 6 hours starting with the end of the test meal) as a marker of lipid digestion and absorption during treatment with verum and placebo.

Main Objective: To evaluate the difference between 13C-exhalation (in terms of cumulative percentage of 13C-dose exhaled per hour after 6 hours starting with the end of the test meal) as a marker of lipid digestion and absorption during treatment with verum and placebo.

Secondary Objective: To evaluate the difference between the maximum percentage of 13C-dose exhaled per hour within 8 hours during treatment with verum and placebo.

To evaluate the difference between 13C-exhalation (in terms of cumulative percentage of 13C-dose exhaled per hour in 1h-intervals, for 8 hours) during treatment with verum and placebo.

To assess the safety and tolerability of trial medication versus placebo using the following safety parameters: vital signs (blood pressure, pulse rate and body weight measure-ments), number of patients inside and outside the normal ranges of laboratory parameters, physical examinations, ECG and incidence and type of Adverse Events.

Secondary ID(s)

BCBe/03/Pan-CPI/003