E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Acromegaly is a chronic metabolic disorder in which there is too much growth hormone and the body tissues gradually enlarge.
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000599 |
E.1.2 | Term | Acromegaly |
E.1.2 | System Organ Class | 10014698 - Endocrine disorders |
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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 |
To determine the effect of Octreolin therapy on Insulin-like Growth Factor 1 (IGF-1) levels |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of Octreolin therapy on Growth Hormone (GH) levels To assess the safety and tolerability of Octreolin in subjects with acromegaly
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacokinetic Sub-Study Determine the PK profile of Octreolin during chronic treatment |
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E.3 | Principal inclusion criteria |
1.Adult subjects, aged 18 to 75 years old, inclusive, at screening visits 2.Subjects with acromegaly defined as documented evidence of GH-secreting pituitary tumor that is abnormally responsive to glucose who are currently receiving somatostatin analog. 3.Subjects able and willing to comply with the requirements of the protocol 4.Subjects able to swallow capsules 5.Subjects able to understand and sign written informed consent to participate in the study
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E.4 | Principal exclusion criteria |
1.Symptomatic cholelithiasis 2.Received pituitary radiotherapy within ten years prior to screening 3.Undergone pituitary surgery within the prior 6 months 4.Clinically significant GI, renal or hepatic disease. 5.Known allergy or hypersensitivity to any of the test compounds or materials 6.Life expectancy of less than 2 years 7.Uncontrolled diabetes 8.Defects in visual fields due to optic chiasmal compression 9.Female patients who are pregnant or lactating 10.Female patients who are of childbearing potential 11.History of immunocompromise, including a positive HIV test result (ELISA and Western blot) 12.History of alcohol or drug abuse 13.Intake of an investigational drug within 30 days before patient inclusion in this study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the IGF-1 concentration at the end of the Core Treatment Period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary efficacy endpoints is the GH concentration at the completion of the Treatment Period. The secondary safety endpoint is the safety and tolerability during the Treatment Period. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | 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 | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 24 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Germany |
Hungary |
Israel |
Italy |
Mexico |
Netherlands |
Poland |
Romania |
Serbia |
Slovakia |
Slovenia |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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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 | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |