Prospektive, offene Studie zur Prüfung der Wirksamkeit der zusätzlichen Gabe des Somatostatinanalogon Octreotid (Sandostatin) bzw. des Dopaminagonisten Cabergolin (Dostinex) bei Patientin mit Akromegalie unter laufender Therapie mit Pegvisomant (Somavert);Prospective, open-label study to evaluate the efficacy of the combined treatment of somatostatin analogue octreotide (Sandostatin) or dopamine agonist cabergoline (Dostinex) in patients with acromegaly on stable therapy of pegvisomant (Somavert). - Efficacy of co-treatment in acromegaly

• Conditions: acromegaly (= growth hormone hypersecretion mostly caused by a pituitary adenoma); MedDRA version: 9.1Level: LLTClassification code 10000599Term: Acromegaly

• Registration Number: EUCTR2007-005585-12-DE
• Lead Sponsor: Department of Internal Medicine of the University of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-06
• Last Update Posted: 20 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified