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 |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058084 |
E.1.2 | Term | Precocious puberty |
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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 |
To assess the efficacy of triptorelin 11.25 mg with respect to the proportion of children who maintain a regression or stabilisation of sexual maturity until the end of the study. |
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E.2.2 | Secondary objectives of the trial |
• To assess the efficacy of triptorelin 11.25 mg on LH response to GnRH tests performed at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on the FSH response to a GnRH test at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on levels of oestradiol in girls or testosterone in boys, at M12, M24, M36 , M48 and final visit (if applicable) both measured by RIA. • To assess the efficacy of triptorelin 11.25 mg on bone maturation at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on growth velocity at M12, M24, M36, M48 and final visit (if applicable). • To assess the variation of predicted adult height at M12, M24, M36, M48 and final visit (if applicable). • To assess the efficacy of triptorelin 11.25 mg on uterine length at M12, M24, M36, M48 and final visit (if applicable). • To assess the clinical safety of the drug.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• The child must have completed study 2 54 52014 143. • The child must have an effective response to 2 injections of triptorelin 11.25 mg according to investigator’s evaluation with no significant treatment side effects. • Written informed consent signed by both parents or by the liable parent or by the legal guardian when applicable.
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E.4 | Principal exclusion criteria |
• The patient has a known hypersensitivity to any of the test materials or related compounds • The patient is unable or unwilling to comply fully with the protocol.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Proportion of children with a stabilization or regression of Tanner pubertal stage at the end of the study, as compared to the stage at study entry (M6 of the phase III study 2 54 52014 143) • Pubertal stage variation at M12, M24, M36, M48 and final visit (if applicable).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
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 | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
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
| 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 | 17 |
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 | 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
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This study starts on the day of the last visit (M6) of the phase III study (2 54 52014 143). It will last until the end of the therapeutic period i.e. at a chronological age of 11 in girls and 13 in boys. Therefore visits M36, M48 are optional visits because if the girl is already 11 and the boy already 13, he/she has finished the study at a prior visit. Final visit occurs only if the child has no ended the study by a complete visit such as M24, M36, or M48.
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |