Acromegaly, pituitary disease, normal IGF1, somatostatin analogues, Pegvisomant
Conditions
Interventions
Weekly sc administration of Pegvisomant (40 mg) or placebo during 16 weeks.
Sponsors
Erasmus University MC
Dept. of Medicine
PO Box 2040
3000 CA Rotterdam NL
Tel: +31 10 703 2862
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent prior to any study related procedures; 2. Male or female aged between 18 and 75 years inclusive; 3. The patient must have had documentation supporting the diagnosis of acromegaly based on elevated GH and/or IGF-1 levels; 4. The patient is treated with lanreotide Autogel or octreotide LAR for at least 6 months and has a serum IGF-1 level above the 60th percentile and below ULN, 28 days after the last injection.
Exclusion criteria
Exclusion criteria: 1. Has undergone pituitary surgery or radiotherapy within 6 months prior to study entry; 2. It is anticipated that the patient will receive pituitary surgery or radiotherapy during the study; 3. Has a history of hypersensitivity to lanreotide, octreotide or pegvisomant or drugs with a similar chemical structure; 4. Has already been treated with a somatostatin analogue associated with pegvisomant; 5. Has received a dopamine agonist within 6 weeks prior to study entry; 6. Has been treated with any unlicensed drug within the last 30 days before study entry; 7. Has abnormal hepatic function at study entry (defined as AST, ALT, gGT, alkaline phosphatase, or total bilirubin above 2 ULN); 8. Is at risk of pregnancy or is lactating. Females of childbearing potential must provide a negative pregnancy test within 5 days before the start of the study and must be using contraception. Non-childbearing potential is defined as post-menopause for at least one year, surgical sterilization or hysterectomy at least three months before the start of the study; 9. Has a history of, or known current, problems with alcohol or drug abuse; 10. Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude; 11. Has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject’s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study; 12. Renal insufficiency, clearance < 60 ml/min; 13. Participation in a clinical trial in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Quality of Life over 16 weeks as assessed by AcroQoL and PASQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin sensitivity after oral glucose loading. and change in: 1. Total body water /body weight; 2. Blood pressure; 3. HbA1c; 4. BNP levels; 5. Ring-size; 6. IGF-I levels; 7. GH levels; 8. PEG-levels. | — |
Contacts
Public ContactS.J.C.M.M. Neggers
Erasmus University MC Dept. of Medicine PO Box 2040
Outcome results
None listed