E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
Acromegaly is a rare disease caused by excessive growth hormone (GH) production usually from a benign pituitary tumour. Insulin-like growth factor-I (IGF-I) is the main mediator of GH action and a marker of disease activity. There are various treatment options for patients with acromegaly: trans-sphenoidal surgery (treatment of choice) dopamine agonists, somatostatine analogues and GH receptor antagonist. Their success rate varies from 35-97%, with higher efficacy being associated with higher cost of treatment. It is known that oestrogen can alter GH and IGF-I and cause symptom improvement in women with acromegaly, but it cannot be given to men. Recently, 2 pilot studies used raloxifene (60 and 120 mg) in women and men with acromegaly and achieved reduction in IGF-I and improvement of symptoms without any side-effects. The aim of this study is to investigate the effect of raloxifene on IGF-I in patients with acromegaly already on a somatostatin analogue - octreotide.
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E.2.2 | Secondary objectives of the trial |
1. to document changes in symptoms and signs and quality of life, if any, in relation to raloxifene treatment 2. to observe what happens to GH and relevant binding proteins (GHBP, IGFBP1-3, ALS), remaining pituitary function and insulin sensitivity 3. to record adverse events, if any.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Man and postmenopausal women with acromegaly Fixed dose of Sandostatin®LAR® for at least three months prior to enrolment Over 18 years of age Safe prolactin levels
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E.4 | Principal exclusion criteria |
History of deep vein thrombosis and/or pulmonary embolism Other conditions known to alter GH/IGF-I (severe hepatic disease, severe renal disease, malnutrition, alcohol and drug abuse) History of relevant food and drug allergies Pregnancy/lactation
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint assessed will be IGF-I change following the additional raloxifene (Evista®) to ongoing octreotide (Sandostatin®LAR®) treatment. |
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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 | Yes |
E.6.4 | Safety | No |
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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
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
| 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 | 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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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |