acromegaly (= growth hormone hypersecretion mostly caused by a pituitary adenoma) MedDRA version: 9.1 Level: LLT Classification code 10000599 Term: Acromegaly
Conditions
Interventions
Trade Name: Somavert
Product Name: Pegvisomant
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Pegvisomant
Current Sponsor code: PN-800,467
Concentration unit:
Sponsors
Department of Internal Medicine of the University of Munich
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with acromegaly caused by pituitary adenoma currently on stable pegvisomant therapy 2. Diabetic patients may be included. Glucose levels must be regularily (every 30 to 60 min) controlled throughout the whole study. 3. Patients must not be co-treated with any other medication for acromegaly. 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
Exclusion criteria: 1. The patient has undergone radiotherapy within the last 2 years. 2. The patient with any relevant acute disease. 3. The patient has a history of hypersensitivity to octreotide (Sandostatin), octreotide LAR (Sandostatin LAR), cabergoline (Dostinex), pegvisomant (Somavert) or drugs with a similar chemical structure. 4. Pregnancy or lactation. 5. The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject´s safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the efficacy of an additional application of somatostatin analogue octreotide (Sandostatin) 100µg s.c. or cabergoline (Dostinex) 0.5mg orally to pegvisomant (Somavert) during an 6 hour or 9 hour profile on endogenous growth hormone (GH) in patients with acromegaly on stable pegvisomant therapy.;Secondary Objective: Investigation of the efficacy of an additional application of somatostatin analogue octreotide (Sandostatin) 100µg s.c. or cabergoline (Dostinex) 0.5mg orally to pegvisomant (Somavert) during an 6 hour or 9 hour profile on pegvisomant levels, insulin, glucose and, in case of the combination of cabergoline (Dostinex), prolactin in patients with acromegaly on stable pegvisomant therapy. ;Primary end point(s): The decrease of endogenous growth hormone levels (GH) due to an additional application of somatostatin analogue octreotide (Sandostatin) 100µg s.c. or cabergoline (Dostinex) 0.5mg orally to pegvisomant (Somavert) during an 6 hour or 9 hour profile in patients with acromegaly on stable pegvisomant therapy. | — |
Countries
Germany
Outcome results
None listed