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| Summary | |
|---|---|
| EudraCT Number: | 2004-004404-21 |
| Sponsor's Protocol Code Number: | SLE-Omega |
| National Competent Authority: | UK - MHRA |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Completed |
| Date on which this record was first entered in the EudraCT database: | 2005-02-17 |
| Trial results | View results |
| A. Protocol Information | |||
|---|---|---|---|
| A.1 | Member State Concerned | UK - MHRA | |
| A.2 | EudraCT number | 2004-004404-21 | |
| A.3 | Full title of the trial |
| |
| A.3.2 | Name or abbreviated title of the trial where available |
| |
| A.4.1 | Sponsor's protocol code number | SLE-Omega | |
| 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 | ||
|---|---|---|
| B.Sponsor: 1 | ||
| B.1.1 | Name of Sponsor | GreenPark Healthcare Trust |
| B.1.3.4 | Country | United Kingdom |
| 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 | |
| B.Sponsor: 2 | ||
| B.1.1 | Name of Sponsor | Queens University Belfast |
| B.1.3.4 | Country | United Kingdom |
| 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 | ||
|---|---|---|
| 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 | Information not present in EudraCT |
| D.2.1.1.1 | Trade name | Omacor |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Pronova Biocare a.s., 1327 Lysaker, Norway |
| D.2.1.2 | Country which granted the Marketing Authorisation | United Kingdom |
| 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.3.1 | Product name | Omacor |
| D.3.4 | Pharmaceutical form | Capsule, soft |
| 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 | Eicosapentaenoic acid |
| D.3.9.1 | CAS number | 25378-27-2. |
| 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 | 1.8 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Docosahexaenoic acid |
| D.3.9.1 | CAS number | 25167-62-8 |
| 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 | 1.2 |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | alpha-tocopherol |
| D.3.9.1 | CAS number | 1406-18-4 |
| D.3.10 | Strength | |
| D.3.10.1 | Concentration unit | mg milligram(s) |
| D.3.10.2 | Concentration type | equal |
| D.3.10.3 | Concentration number | 16 |
| 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) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| D.3.11.3.2 | Gene therapy medical product | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| D.3.11.6 | Immunological medicinal product (such as vaccine, allergen, immune serum) | Information not present in EudraCT |
| D.3.11.7 | Plasma derived medicinal product | Information not present in EudraCT |
| D.3.11.8 | Extractive medicinal product | Information not present in EudraCT |
| D.3.11.9 | Recombinant medicinal product | Information not present in EudraCT |
| D.3.11.10 | Medicinal product containing genetically modified organisms | Information not present in EudraCT |
| D.3.11.11 | Herbal medicinal product | Yes |
| D.3.11.12 | Homeopathic medicinal product | Information not present in EudraCT |
| D.3.11.13 | Another type of medicinal product | Information not present in EudraCT |
| D.8 Information on Placebo | ||
|---|---|---|
| D.8 Placebo: 1 | ||
| D.8.1 | Is a Placebo used in this Trial? | Yes |
| D.8.3 | Pharmaceutical form of the placebo | Capsule, soft |
| D.8.4 | Route of administration of the placebo | Oral use |
| E. General Information on the Trial | |||
|---|---|---|---|
| E.1 Medical condition or disease under investigation | |||
| E.1.1 | Medical condition(s) being investigated |
| |
| MedDRA Classification | |||
| 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 |
| |
| E.2.2 | Secondary objectives of the trial |
| |
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT | |
| E.3 | Principal inclusion criteria |
| |
| E.4 | Principal exclusion criteria |
| |
| E.5 End points | |||
| E.5.1 | Primary end point(s) |
| |
| E.6 and E.7 Scope of the trial | |||
| E.6 | Scope of the trial | ||
| E.6.1 | Diagnosis | Information not present in EudraCT | |
| E.6.2 | Prophylaxis | Information not present in EudraCT | |
| E.6.3 | Therapy | Yes | |
| E.6.4 | Safety | Information not present in EudraCT | |
| E.6.5 | Efficacy | Yes | |
| E.6.6 | Pharmacokinetic | Information not present in EudraCT | |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT | |
| E.6.8 | Bioequivalence | Information not present in EudraCT | |
| E.6.9 | Dose response | Information not present in EudraCT | |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT | |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT | |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT | |
| E.6.13 | Others | Information not present in EudraCT | |
| E.7 | Trial type and phase | ||
| E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT | |
| E.7.1.1 | First administration to humans | Information not present in EudraCT | |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT | |
| E.7.1.3 | Other | Information not present in EudraCT | |
| E.7.1.3.1 | Other trial type description | ||
| E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT | |
| E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT | |
| E.7.4 | Therapeutic use (Phase IV) | Yes | |
| E.8 Design of the trial | |||
| E.8.1 | Controlled | Yes | |
| E.8.1.1 | Randomised | Yes | |
| E.8.1.2 | Open | Information not present in EudraCT | |
| E.8.1.3 | Single blind | Information not present in EudraCT | |
| E.8.1.4 | Double blind | Yes | |
| E.8.1.5 | Parallel group | Yes | |
| E.8.1.6 | Cross over | Information not present in EudraCT | |
| E.8.1.7 | Other | Information not present in EudraCT | |
| E.8.2 | Comparator of controlled trial | ||
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT | |
| E.8.2.2 | Placebo | Yes | |
| E.8.2.3 | Other | Information not present in EudraCT | |
| 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 | Information not present in EudraCT | |
| E.8.5 | The trial involves multiple Member States | Information not present in EudraCT | |
| E.8.6 Trial involving sites outside the EEA | |||
| E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT | |
| 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 | 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 |
| |
| 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 | ||
| F. Population of Trial Subjects | ||
|---|---|---|
| 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) | Information not present in EudraCT |
| 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 | Information not present in EudraCT |
| F.3.3.1 | Women of childbearing potential not using contraception | No |
| F.3.3.2 | Women of child-bearing potential using contraception | Information not present in EudraCT |
| 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 | No |
| F.4 Planned number of subjects to be included | ||
| F.4.1 | In the member state | 60 |
| F.4.2 | For a multinational trial | |
| F.4.2.2 | In the whole clinical trial | 60 |
| 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 Decision | 2004-12-10 |
| N. | Ethics Committee Opinion of the trial application | Favourable |
| N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion | |
| N. | Date of Ethics Committee Opinion | 2003-06-01 |
| P. End of Trial | ||
|---|---|---|
| P. | End of Trial Status | Completed |
| P. | Date of the global end of the trial | 2007-02-01 |