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 hormone disorder usually due to secretion of excess growth hormone (GH) from a pituitary tumour in the pituitary gland. Pegvisomant is a relatively new and effective treatment for acromegaly. It is currently only licensed for treatment of acromegaly which is resistant to treatment with other drugs. High doses of pegvisomant may be required in order to fully control acromegaly. This is very expensive. Cabergoline is another drug which is effective in treating acromegaly. It is relatively inexpensive but usually unable to control acromegaly completely when used alone. We would like to address the question as to whether using a combination of pegvisomant and cabergoline would allow us to use lower doses of pegvisomant to achieve good acromegaly control at significantly lower cost |
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E.2.2 | Secondary objectives of the trial |
To ascertain the proportion of patients who have good acromegaly control on cabergoline alone and the dose required for this. To assess signs and symptoms of acromegaly and quality of life in patients treated with cabergoline alone and cabergoline in combination with pegvisomant. To assess some biochemical parameters which are affected by acromegaly. This includes lipids, cardiovascular risk factors and glucose tolerance. To assess serum levels of pegvisomant and whether these are affected by the presence of cabergoline. Isolated case reports exist of increased serum pegvisomant levels in the presence of somatostatin analogues. It would be pertinent to see if this was the case with cabergoline.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1 Established diagnosis of acromegaly 2 IGF-I> upper limit of normal following washout period of current drugs 3 Age> 18 years |
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E.4 | Principal exclusion criteria |
1 Other conditions that may result in abnormal GH or IGF-I (e.g. severe hepatic disease, severe renal disease, malnutrition, treatment with levadopa, heroin abuse) 2 Do not have the ability to fully comprehend the nature of the study, to follow instructions, and/or cooperate with study procedures. 3 ALT or AST >3x ULN or clinically significant hepatic disease. 4 Visual field defects or other neurological symptoms due to tumour mass. 5 Have a history of relevant drug and/or food allergies or are on regular treatment with any medication that may be expected to interfere with projected study results. 6 Have received another experimental medication that may be expected to interfere with projected study results 7 Refuse to use adequate contraception to prevent pregnancy during the study 8 Are unwilling or unable to self-administer study medication on a daily basis 9 Are unable to adhere to the visit schedule outlined in the protocol 10 Have known or suspected drug/alcohol abuse 11 Women who are pregnant and women who are lactating
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E.5 End points |
E.5.1 | Primary end point(s) |
The absolute IGF I values for the 30 patients after treatment with cabergoline alone, cabergoline with pegvisomant and pegvisomant alone as described in the protocol |
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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 | 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 | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
cabergoline with pegvisomant VS pegvisomant alone |
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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.8.5 | The trial involves multiple Member States | Yes |
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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The end of the trial is when all trial patients have undergone 18 weeks of dose titration with cabergoline followed by 12 weeks of cabergoline with pegvisomant and a further 12 weeks of pegviomant alone as described in the protocol |
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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 | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |