Kliniske forsøg Nct side
| Summary | |
|---|---|
| EudraCT Number: | 2004-000866-11 |
| Sponsor's Protocol Code Number: | 7164-L-01 |
| 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: | 2004-09-24 |
| Trial results | View results |
| A. Protocol Information | |||
|---|---|---|---|
| A.1 | Member State Concerned | Italy - Italian Medicines Agency | |
| A.2 | EudraCT number | 2004-000866-11 | |
| A.3 | Full title of the trial |
| |
| A.4.1 | Sponsor's protocol code number | 7164-L-01 | |
| 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 | ZAMBON GROUP |
| B.1.3.4 | Country | Italy |
| B.3.1 and B.3.2 | Status of the sponsor | 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 | Biocalyptol |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Mipharm SpA |
| D.2.1.2 | Country which granted the Marketing Authorisation | France |
| 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 | falcodina |
| D.3.4 | Pharmaceutical form | Syrup |
| 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 | Pholcodine |
| D.3.9.2 | Current sponsor code | 7164 |
| 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 | 19.5 |
| 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 | Yes |
| D.3.11.13.1 | Other medicinal product type | IMP chemical origin |
| D.IMP: 2 | ||
| D.1.2 and D.1.3 | IMP Role | Comparator |
| 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 | Vicks tosse sedativo Fl 180ml |
| D.2.1.1.2 | Name of the Marketing Authorisation holder | Procter & Gable 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 | destrometorfano |
| D.3.4 | Pharmaceutical form | Syrup |
| 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 | Dextromethorphan |
| D.3.9.1 | CAS number | 6700-34-1 |
| 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 | 20 |
| 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 | Yes |
| D.3.11.13.1 | Other medicinal product type | IMP chemical origin |
| 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) | Yes | |||||||||
| 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 | Information not present in EudraCT | |||||||||
| E.8.1.3 | Single blind | Information not present in EudraCT | |||||||||
| E.8.1.4 | Double blind | Information not present in EudraCT | |||||||||
| E.8.1.5 | Parallel group | Information not present in EudraCT | |||||||||
| 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 | Information not present in EudraCT | |||||||||
| E.8.2.3 | Other | Information not present in EudraCT | |||||||||
| E.8.3 | The trial involves single site in the Member State concerned | Information not present in EudraCT | |||||||||
| 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 | ||||||||||
| 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 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 2004-09-24. | Yes |
| 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 | |
| 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 | 2004-08-06 |
| N. | Ethics Committee Opinion of the trial application | Favourable |
| N. | Ethics Committee Opinion: Reason(s) for unfavourable opinion | |
| N. | Date of Ethics Committee Opinion | 2004-06-03 |
| P. End of Trial | ||
|---|---|---|
| P. | End of Trial Status | Completed |