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    Summary
    EudraCT Number:2005-000562-38
    Sponsor's Protocol Code Number:BCBe/03/Pan-CPI/002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-09-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2005-000562-38
    A.3Full title of the trial
    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 OF
    13C-MIXED TRIGLYCERIDE BREATH TEST
    A.3.2Name or abbreviated title of the trial where available
    CPI 002
    A.4.1Sponsor's protocol code numberBCBe/03/Pan-CPI/002
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBerlin-Chemie AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.1.1.1Trade name Mezym F
    D.2.1.1.2Name of the Marketing Authorisation holderBerlin-Chemie Menarini Group
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMezym F
    D.3.2Product code Pancreatin
    D.3.4Pharmaceutical form Gastro-resistant tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPancreatin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number10000 IU lipase
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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 pancreatitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10033628
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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 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.
    E.4Principal 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.
    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.
    E.5 End points
    E.5.1Primary 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other 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.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial 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
    Please refer to trial protocol, final version 1.0, section 9.3.4.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the end of the trial the patients will be in medical care by their attending physician.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2005-10-31
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