Summary
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EudraCT Number: | 2009-010921-38 |
Sponsor's Protocol Code Number: | MDL_2009_27155 |
National Competent Authority: | Netherlands - Competent Authority |
Clinical Trial Type: | EEA CTA |
Trial Status: | Ongoing |
Date on which this record was first entered in the EudraCT database: | 2009-03-02 |
Trial results |
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A. Protocol Information
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A.1 | Member State Concerned | Netherlands - Competent Authority | |
A.2 | EudraCT number | 2009-010921-38 | |
A.3 | Full title of the trial |
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A.3.2 | Name or abbreviated title of the trial where available |
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A.4.1 | Sponsor's protocol code number | MDL_2009_27155 | |
A.7 | Trial is part of a Paediatric Investigation Plan | Information not present in EudraCT | |
A.8 | EMA Decision number of Paediatric Investigation Plan |
B. Sponsor Information
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B.Sponsor: 1 | ||
B.1.1 | Name of Sponsor | UMC Utrecht |
B.1.3.4 | Country | Netherlands |
B.3.1 and B.3.2 | Status of the sponsor | Non-Commercial |
B.4 Source(s) of Monetary or Material Support for the clinical trial: | ||
B.4.1 | Name of organisation providing support | |
B.4.2 | Country | |
B.5 Contact point designated by the sponsor for further information on the trial | ||
B.5.1 | Name of organisation | |
B.5.2 | Functional name of contact point |
D. IMP Identification
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D.IMP: 1 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Salofalk |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Dr Falk Pharma GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Netherlands |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Granules |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | mesalazine |
D.3.9.1 | CAS number | 89-57-6 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | mg/kg milligram(s)/kilogram |
D.3.10.2 | Concentration type | range |
D.3.10.3 | Concentration number | 20 to 25 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | pharmaceutical |
D.IMP: 2 | ||
D.1.2 and D.1.3 | IMP Role | Test |
D.2 | Status of the IMP to be used in the clinical trial | |
D.2.1 | IMP to be used in the trial has a marketing authorisation | Yes |
D.2.1.1.1 | Trade name | Ursofalk |
D.2.1.1.2 | Name of the Marketing Authorisation holder | Dr Falk Pharma GmbH |
D.2.1.2 | Country which granted the Marketing Authorisation | Netherlands |
D.2.5 | The IMP has been designated in this indication as an orphan drug in the Community | No |
D.2.5.1 | Orphan drug designation number | |
D.3 Description of the IMP | ||
D.3.4 | Pharmaceutical form | Coated tablet |
D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
D.3.7 | Routes of administration for this IMP | Oral use |
D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
D.3.8 | INN - Proposed INN | ursodeoxycholic acid |
D.3.9.1 | CAS number | 128-13-2 |
D.3.10 | Strength | |
D.3.10.1 | Concentration unit | g gram(s) |
D.3.10.2 | Concentration type | equal |
D.3.10.3 | Concentration number | 4 |
D.3.11 The IMP contains an: | ||
D.3.11.1 | Active substance of chemical origin | Yes |
D.3.11.2 | Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) | No |
The IMP is a: | ||
D.3.11.3 | Advanced Therapy IMP (ATIMP) | Information not present in EudraCT |
D.3.11.3.1 | Somatic cell therapy medicinal product | No |
D.3.11.3.2 | Gene therapy medical product | No |
D.3.11.3.3 | Tissue Engineered Product | Information not present in EudraCT |
D.3.11.3.4 | Combination ATIMP (i.e. one involving a medical device) | Information not present in EudraCT |
D.3.11.3.5 | Committee on Advanced therapies (CAT) has issued a classification for this product | Information not present in EudraCT |
D.3.11.4 | Combination product that includes a device, but does not involve an Advanced Therapy | Information not present in EudraCT |
D.3.11.5 | Radiopharmaceutical medicinal product | No |
D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | No |
D.3.11.7 | Plasma derived medicinal product | No |
D.3.11.8 | Extractive medicinal product | No |
D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
D.3.11.10 | Medicinal product containing genetically modified organisms | No |
D.3.11.11 | Herbal medicinal product | No |
D.3.11.12 | Homeopathic medicinal product | No |
D.3.11.13 | Another type of medicinal product | Yes |
D.3.11.13.1 | Other medicinal product type | pharmaceutical |
D.8 Information on Placebo
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D.8 Placebo: 1 | ||
D.8.1 | Is a Placebo used in this Trial? | Yes |
D.8.3 | Pharmaceutical form of the placebo | Granules |
D.8.4 | Route of administration of the placebo | Oral use |
D.8 Placebo: 2 | ||
D.8.1 | Is a Placebo used in this Trial? | Yes |
D.8.3 | Pharmaceutical form of the placebo | Coated tablet |
D.8.4 | Route of administration of the placebo | Oral use |
E. General Information on the Trial
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E.1 Medical condition or disease under investigation | |||||||||||||||||
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification | |||||||||||||||||
E.1.2 Medical condition or disease under investigation | |||||||||||||||||
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E.1.3 | Condition being studied is a rare disease | No | |||||||||||||||
E.2 Objective of the trial | |||||||||||||||||
E.2.1 | Main objective of the trial |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No | |||||||||||||||
E.3 | Principal inclusion criteria |
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E.4 | Principal exclusion criteria |
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E.5 End points | |||||||||||||||||
E.5.1 | Primary end point(s) |
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E.6 and E.7 Scope of the trial | |||||||||||||||||
E.6 | Scope of the trial | ||||||||||||||||
E.6.1 | Diagnosis | No | |||||||||||||||
E.6.2 | Prophylaxis | Yes | |||||||||||||||
E.6.3 | Therapy | Yes | |||||||||||||||
E.6.4 | Safety | No | |||||||||||||||
E.6.5 | Efficacy | Yes | |||||||||||||||
E.6.6 | Pharmacokinetic | No | |||||||||||||||
E.6.7 | Pharmacodynamic | No | |||||||||||||||
E.6.8 | Bioequivalence | No | |||||||||||||||
E.6.9 | Dose response | No | |||||||||||||||
E.6.10 | Pharmacogenetic | No | |||||||||||||||
E.6.11 | Pharmacogenomic | No | |||||||||||||||
E.6.12 | Pharmacoeconomic | No | |||||||||||||||
E.6.13 | Others | Yes | |||||||||||||||
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase | ||||||||||||||||
E.7.1 | Human pharmacology (Phase I) | No | |||||||||||||||
E.7.1.1 | First administration to humans | No | |||||||||||||||
E.7.1.2 | Bioequivalence study | No | |||||||||||||||
E.7.1.3 | Other | No | |||||||||||||||
E.7.1.3.1 | Other trial type description | ||||||||||||||||
E.7.2 | Therapeutic exploratory (Phase II) | Yes | |||||||||||||||
E.7.3 | Therapeutic confirmatory (Phase III) | No | |||||||||||||||
E.7.4 | Therapeutic use (Phase IV) | No | |||||||||||||||
E.8 Design of the trial | |||||||||||||||||
E.8.1 | Controlled | Yes | |||||||||||||||
E.8.1.1 | Randomised | Yes | |||||||||||||||
E.8.1.2 | Open | No | |||||||||||||||
E.8.1.3 | Single blind | No | |||||||||||||||
E.8.1.4 | Double blind | Yes | |||||||||||||||
E.8.1.5 | Parallel group | Yes | |||||||||||||||
E.8.1.6 | Cross over | No | |||||||||||||||
E.8.1.7 | Other | No | |||||||||||||||
E.8.2 | Comparator of controlled trial | ||||||||||||||||
E.8.2.1 | Other medicinal product(s) | Yes | |||||||||||||||
E.8.2.2 | Placebo | Yes | |||||||||||||||
E.8.2.3 | Other | 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.8.4.1 | Number of sites anticipated in Member State concerned | 2 | |||||||||||||||
E.8.5 | The trial involves multiple Member States | No | |||||||||||||||
E.8.6 Trial involving sites outside the EEA | |||||||||||||||||
E.8.6.1 | Trial being conducted both within and outside the EEA | No | |||||||||||||||
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT | |||||||||||||||
E.8.7 | Trial has a data monitoring committee | Yes | |||||||||||||||
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 |
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E.8.9 Initial estimate of the duration of the trial | |||||||||||||||||
E.8.9.1 | In the Member State concerned years | 2 | |||||||||||||||
E.8.9.1 | In the Member State concerned months | 0 | |||||||||||||||
E.8.9.1 | In the Member State concerned days | 0 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial years | 0 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial months | 0 | |||||||||||||||
E.8.9.2 | In all countries concerned by the trial days | 0 |
F. Population of Trial Subjects
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F.1 Age Range | |||
F.1.1 | Trial has subjects under 18 | No | |
F.1.1.1 | In Utero | Information not present in EudraCT | |
F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | Information not present in EudraCT | |
F.1.1.3 | Newborns (0-27 days) | Information not present in EudraCT | |
F.1.1.4 | Infants and toddlers (28 days-23 months) | Information not present in EudraCT | |
F.1.1.5 | Children (2-11years) | Information not present in EudraCT | |
F.1.1.6 | Adolescents (12-17 years) | Information not present in EudraCT | |
F.1.2 | Adults (18-64 years) | Yes | |
F.1.3 | Elderly (>=65 years) | No | |
F.2 Gender | |||
F.2.1 | Female | Yes | |
F.2.2 | Male | Yes | |
F.3 Group of trial subjects | |||
F.3.1 | Healthy volunteers | No | |
F.3.2 | Patients | Yes | |
F.3.3 | Specific vulnerable populations | Yes | |
F.3.3.1 | Women of childbearing potential not using contraception | No | |
F.3.3.2 | Women of child-bearing potential using contraception | Yes | |
F.3.3.3 | Pregnant women | No | |
F.3.3.4 | Nursing women | No | |
F.3.3.5 | Emergency situation | No | |
F.3.3.6 | Subjects incapable of giving consent personally | No | |
F.3.3.7 | Others | Yes | |
F.3.3.7.1 | Details of other specific vulnerable populations |
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F.4 Planned number of subjects to be included | |||
F.4.1 | In the member state | 45 |
G. Investigator Networks to be involved in the Trial
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N. Review by the Competent Authority or Ethics Committee in the country concerned
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N. | Competent Authority Decision | Authorised |
N. | Date of Competent Authority Decision | 2009-03-18 |
N. | Ethics Committee Opinion of the trial application | Favourable |
N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion |
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N. | Date of Ethics Committee Opinion | 2009-09-08 |
P. End of Trial
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P. | End of Trial Status | Ongoing |