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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2008-000500-83-LT |
Date of registration:
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09/06/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A phase II exploratory, ascending dose, multicentre study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability, of BIM23A760 in acromegalic patients.
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Scientific title:
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A phase II exploratory, ascending dose, multicentre study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability, of BIM23A760 in acromegalic patients. |
Date of first enrolment:
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15/07/2008 |
Target sample size:
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24 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000500-83 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Belgium
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Italy
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Latvia
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Lithuania
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients must fulfil the following: 1. The patient has provided written informed consent prior to any study related procedures. 2. The patient age is between 18 and 75 years inclusive. 3. The patient is male, or a woman who has been post menopausal for at least 3 years. In addition women with a documented infertility (natural or acquired) may be included. 4. The patient must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception as defined in the ICH M3 guideline, and this should be continued for two months after the Investigational Medicinal Product (IMP) administration. 5. The patient must have documentation supporting the diagnosis of acromegaly, including elevated GH and/or insulin-like growth factor - I (IGF-I) levels. 6. The patient has a mean serum GH concentration > 3.5 µg/l during a 5h profile and an IGF-I serum level above normal during the screening period.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: Patients will not be included in the study if: 1. The patient has undergone pituitary surgery within 3 months prior to study entry or within 6 weeks in case of macroadenoma. 2. The patient has undergone radiotherapy anytime prior to study entry. 3. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study. 4. The patient has received long acting somatostatin analogues within 6 months prior to study entry. 5. The patient has received dopamine agonist or short acting octreotide within 1 month before entering the study. 6. The patient has received GH antagonist at anytime prior to study entry. 7. The patient is known for not being controlled by somatostatin analogues at anytime prior to study entry. 8. The patient has any known uncontrolled cardiovascular disease and/or concomitant medication(s) associated with risk of severe hypotension. 9. The patient has any known valvular disease. 10. The patient has any known uncontrolled metabolic disease. 11. The patient has insulin-treated diabetes or HbA1c > 7.5%. 12. The patient has clinically significant hepatic abnormalities and/or AST and/or ALT > 3 ULN during the screening period. 13. The patient has any severe renal or hepatic insufficiency. 14. The patient is receiving any Hormone Replacement Therapy (HRT). 15. The patient is receiving neuroleptic antipsychotic/antiemetic drugs. 16. The patient has abnormal findings during the screening period, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient’s safety. 17. The patient has been treated with any other IMP prior to the first study visit without undergoing a wash-out period of 7 times the elimination half-life of the investigational compound. 18. The patient has a known hypersensitivity to any of the test materials or related compounds. 19. The patient is likely to require treatment during the study with drugs that are not permitted by the study protocol. 20. The patient has a history of, or known current, problems with alcohol or drug abuse. 21. The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Acromegaly MedDRA version: 9.1
Level: LLT
Classification code 10000599
Term: Acromegaly
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Intervention(s)
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Product Code: BIM23A760 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Not available CAS Number: 868562-36-1 Current Sponsor code: BIM23A760 Other descriptive name: Dopastatin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5-
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Primary Outcome(s)
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Main Objective: To investigate the pharmacodynamics (PD) of BIM 23A760, administered by single subcutaneous (s.c.) injection to acromegalic patients.
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Secondary Objective: To investigate the pharmacokinetics (PK), safety and tolerability of BIM 23A760, administered by single s.c. injection to acromegalic patients.
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Primary end point(s): PD response: Maximum observed % inhibition of GH.
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Secondary ID(s)
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2-55-52060-002
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Source(s) of Monetary Support
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Results
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Results available:
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