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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-005180-25
    Sponsor's Protocol Code Number:NM/BL-IIa-1106
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-31
    Trial 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 number2006-005180-25
    A.3Full title of the trial
    A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiency
    Randomized, double-blind, placebo-controlled, single period, parallel group design
    A.4.1Sponsor's protocol code numberNM/BL-IIa-1106
    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 SponsorNordmark Arzneimittel GmbH
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/049/05
    D.3 Description of the IMP
    D.3.2Product code LU 70274
    D.3.4Pharmaceutical form Capsule*
    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.3.9.2Current sponsor codeLU 70274
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90000
    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 No
    D.3.11.8Extractive medicinal product No
    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 Yes
    D.3.11.13.1Other medicinal product typebacterial lipase
    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 placeboCapsule*
    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
    Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety, tolerability, and pharmacodynamics of multiple doses of LU 70274.
    To investigate the concentration of fat and lipase in stool.
    To investigate the intensity of abdominal pain and gastrointestinal discomfort.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and follow instructions during the study.
    2. Signed informed consent.
    3. Caucasian male patients aged between 18 and 50 years with CF transmembrane conductance regulator mutations on both alleles or two positive sweat tests, with pancreas insufficiency who are able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study (i.e., Study Days 2-4).
    4. Pancreatic elastase E1 < 200 g/g in stool at screening,
    5. General good physical health as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory tests.
    6. Weight within the normal range according to accepted values for the Body mass index (BMI) within 18.5-29.9 kg/m2.
    7. Normal blood pressure (Systolic Blood Pressure (SBP) >95, <139 mmHg; Diastolic Blood Pressure (DBP) >55, <90 mmHg) measured after 5 min rest in supine position.
    8. A heart rate at rest of >45 and <99 b/min measured after 5 min rest in supine position.
    9. ECG recording without clinically significant abnormalities.
    10. Having had no febrile or infectious illness for at least seven days prior to the first administration of the IMPs of the study.
    E.4Principal exclusion criteria
    1. Acute exacerbations of CF.
    2. History of infection with burkholderia cepacia (B. cepacia) or methicillin-resistant staphylococcus aureus within the last six months.
    3. Clinically not acceptable lung function, as determined by FEV1 (Forced Expiratory Volume in one second) < 40% predicted
    4. Distal Intestinal Obstruction Syndrome within the past 12 months.
    5. Oral antacid therapy with H2-antagonists or proton pump inhibitors within the past 3 months.
    6. Systemic corticosteroids within the past 3 months.
    7. Positive test for human immunodeficiency virus (HIV) antibodies.
    8. Positive hepatitis-B-virus-surface antigen (HBsAg) test.
    9. Positive Anti-hepatitis-C-virus antibodies (Anti-HCV) test.
    10. Laboratory values suggesting an unknown disease in the opinion of the investigator and/or requiring further clinical evaluation assessed by the investigator (especially ALT, aspartate aminotransferase (AST), gamma glutamyltranspeptidase (GGT)).
    11. Any history of alcohol or drug abuse.
    12. More than moderate alcohol consumption (>35 g of ethanol regularly per day or >245 g regularly per week).
    13. Ethanol consumption within 48 hours prior to administration verified by alcohol breath test (Alcotest®).
    14. Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis abuse (verified by Mahsan "Kombi/DOA2-" and Mahsan "Kombi4/O2T Schnelltest").
    15. More than moderate smoker (>10 cigarettes/day).
    16. Demonstrating excess in xanthine consumption (more than five cups of coffee or equivalent per day).
    17. Any history of drug hypersensitivity that is assessed to be of clinical relevance, asthma, urticaria or other severe allergic diathesis.
    18. Any history of hypersensitivity to the IMP.
    19. Any disease state – other than CF – that, in the opinion of the investigator, does not allow study participation.
    20. Participation in the treatment phase of a clinical study within 30 days prior to the treatment phase of this study.
    21. Blood donation within 30 days prior to inclusion in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability:
    Physical examination, vital signs, electrocardiogram (ECG), adverse events (AEs), subjective well-being, clinical chemistry, hematology, urine analysis, and overall tolerability, total immunoglobulin G (IgG) in serum.

    Pharmacodynamics:
    Fat in stool and stool weight.

    Lipase concentrations in stool:
    Amount of lipase excreted.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.6Cross over No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Last subject last visit (see chapter 9.3.3 and 9.3.4 of the protocol)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state20
    F.4.2 For a multinational trial
    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)
    see chapter 9.3.3 and 9.3.4

    see also chapter 9.5.1.3
    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 Decision2006-12-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-04-23
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