Clinical Trial Page
| Summary | |
|---|---|
| EudraCT Number: | 2005-002553-50 |
| Sponsor's Protocol Code Number: | 29/2005/O- CP18549 |
| National Competent Authority: | Italy - Italian Medicines Agency |
| Clinical Trial Type: | EEA CTA |
| Trial Status: | Completed |
| Date on which this record was first entered in the EudraCT database: | 2007-02-22 |
| Trial results | |
| A. Protocol Information | |||
|---|---|---|---|
| A.1 | Member State Concerned | Italy - Italian Medicines Agency | |
| A.2 | EudraCT number | 2005-002553-50 | |
| A.3 | Full title of the trial |
| |
| A.4.1 | Sponsor's protocol code number | 29/2005/O- CP18549 | |
| 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 | AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI |
| B.1.3.4 | Country | Italy |
| 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 | Yes |
| D.2.1.1.1 | Trade name | Contramal 5F 100mg 2ml |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Formenti |
| D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
| 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 | tramadolo |
| D.3.4 | Pharmaceutical form | Solution for injection |
| D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
| D.3.7 | Routes of administration for this IMP | Intravenous use |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Tramadol |
| D.3.9.1 | CAS number | 36282-47-0 |
| 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 | 100 |
| 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 | 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 | 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 | No |
| 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 | Perfalgan inf 12FL 100ml/10mg |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | UPSA Srl |
| D.2.1.2 | Country which granted the Marketing Authorisation | Italy |
| 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 | paracetamolo |
| D.3.4 | Pharmaceutical form | Solution for infusion |
| D.3.4.1 | Specific paediatric formulation | Information not present in EudraCT |
| D.3.7 | Routes of administration for this IMP | Intravenous use |
| D.3.8 to D.3.10 IMP Identification Details (Active Substances) | ||
| D.3.8 | INN - Proposed INN | Paracetamol |
| D.3.9.1 | CAS number | 103-90-2 |
| 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 |
| 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 | 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 | 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 | No |
| D.8 Information on Placebo |
|---|
| 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.1.2 Medical condition or disease under investigation | |||||||||||
| |||||||||||
| 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 | No | |||||||||
| E.6.2 | Prophylaxis | No | |||||||||
| E.6.3 | Therapy | Yes | |||||||||
| E.6.4 | Safety | Yes | |||||||||
| E.6.5 | Efficacy | Yes | |||||||||
| E.6.6 | Pharmacokinetic | No | |||||||||
| E.6.7 | Pharmacodynamic | No | |||||||||
| E.6.8 | Bioequivalence | Information not present in EudraCT | |||||||||
| E.6.9 | Dose response | No | |||||||||
| E.6.10 | Pharmacogenetic | Information not present in EudraCT | |||||||||
| E.6.11 | Pharmacogenomic | No | |||||||||
| E.6.12 | Pharmacoeconomic | No | |||||||||
| E.6.13 | Others | Information not present in EudraCT | |||||||||
| 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) | No | |||||||||
| E.7.3 | Therapeutic confirmatory (Phase III) | No | |||||||||
| 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 | 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 | No | |||||||||
| E.8.2.3 | Other | 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.8.5 | 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 | 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 | ||||||||||
| E.8.9.1 | In the Member State concerned months | ||||||||||
| 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 | No |
| F.1.1.2 | Preterm newborn infants (up to gestational age < 37 weeks) | No |
| F.1.1.3 | Newborns (0-27 days) | No |
| F.1.1.4 | Infants and toddlers (28 days-23 months) | No |
| F.1.1.5 | Children (2-11years) | No |
| F.1.1.6 | Adolescents (12-17 years) | No |
| F.1.2 | Adults (18-64 years) | Yes |
| F.1.3 | Elderly (>=65 years) | Yes |
| 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 | 110 |
| 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 | 2005-05-24 |
| N. | Ethics Committee Opinion of the trial application | Favourable |
| N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion | |
| N. | Date of Ethics Committee Opinion | 2005-05-24 |
| P. End of Trial | ||
|---|---|---|
| P. | End of Trial Status | Completed |