E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acromegaly due to GH-secreting hypophysial adenoma, persistent after surgical adenomectomy, external radiotherapy or medical therapy with analogous of somatostatin. |
|
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 | 10000599 |
E.1.2 | Term | Acromegaly |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety assessment of rosiglitazone at higher dose than the ones provided by the technical form, in 5 patients with active acromegaly or resistant to conventional treatments. |
|
E.2.2 | Secondary objectives of the trial |
Assessment of reduction of the biochemical parameters of disease's activity (serum concentrations of GH and IGF-1) in 5 patients with active acromegaly or resistant to conventional treatments. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
a.Male and/or female subjects, 20 years < age < 70 years; b.Subjects with acromegaly due to GH-secreting hypophysial adenoma, persistent after surgical adenomectomy, external radiotherapy or medical therapy with analogous of somatostatin; c.Documented evidence of a written informed consent, the subject has signed and dated the informed consent document; d.Aware subjects and able to observe all procedures provided for the study, including medical examinations, compliance with treatment and laboratory examinations. |
|
E.4 | Principal exclusion criteria |
a.Patients with age < 20 years and > 70 years; b.Patients with cardiac insufficiency or history of cardiac insufficiency (classes NYHA I-IV); c.Patients with diabetes mellitus treated with insulin; d.Patients with hypersensitivity to rosiglitazone or to the excipients of the tablet; e. Patients with hepatic insufficiency; f.Patients with renal insufficiency. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Objective analysis, including the measurement of corporeal weight, cardiac frequency and arterial pressure; laboratory analysis: hemochromo, examination of hepatic fuctionality, renal fuctionality, glycaemia, insulinemia, lipidic profile, total proteins, protein electrophoresis, plasmatic electrolytes, standard test of the urine. |
|
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 | 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 | 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) | 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 | 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) | 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
| 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 | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |