Acute Application of Pegvisomant and Octreotide in Acromegaly

NCT00595140 | Completed Phase 4

• 1 other identifier: EudraCT-Nr. 2007-005585-12
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate the efficacy of an acute additional application of the somatostatin analogue octreotide 100µg s.c. or the dopamine agonist cabergoline 0.5mg p.o. to the receptor antagonist pegvisomant during a 6 or 9 hour profile on reducing endogenous growth hormone in patients with acromegaly on stable pegvisomant therapy.

Conditions

Acromegaly

Keywords

Acromegaly,; growth hormone receptor antagonist,; somatostatin analogue,; combined medical treatment,; acute effect,; endogenous GH

Outcome Measures

Primary Outcomes (1)

• The decrease of endogenous growth hormone

  6 or 9 hours

Secondary Outcomes (1)

• The course of glucose, insulin and pegvisomant during the profiles

  6 or 9 hours

Study Arms (3)

1

NO INTERVENTION

patients with acromegaly on stable pegvisomant therapy

Drug: pegvisomant

2

ACTIVE COMPARATOR

Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg

Drug: combination with somatostatin analogue octreotide

3

ACTIVE COMPARATOR

Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally

Drug: combination with dopamine agonist cabergoline

Interventions

pegvisomant DRUG

growth hormone receptor antagonist pegvisomant in patients´ individual dose

Also known as: Pegvisomant:, SOMAVERT 10 mg: EU/1/02/240/001, SOMAVERT 15 mg: EU/1/02/240/002, SOMAVERT 20 mg: EU/1/02/240/003, SOMAVERT 20 mg: EU/1/02/240/004

1

combination with somatostatin analogue octreotide DRUG

s.c., 100µg, one time

Also known as: Octreotide: Sandostatin 100µg: MA number 29423.01.00

2

combination with dopamine agonist cabergoline DRUG

oral, 0.5mg, one time

Also known as: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with acromegaly currently on stable pegvisomant therapy
• patients with diabetes mellitus may be included. Glucose levels must be controlled regularly throughout the study
• patients must not be co-treated with any other medication for acromegaly

You may not qualify if:

• radiotherapy within the last 2 years
• any relevant acute disease
• history of hypersensitivity against any of the used drugs
• pregnancy or lactation
• abnormal baseline findings

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Medizinische Klinik - Innenstadt of the University of Munich

Munich, 80336, Germany

Location

MeSH Terms

Conditions

Acromegaly

Interventions

pegvisomant

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Jochen Schopohl, MD

  Medizinische Klinik - Innenstadt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 1, 2008

Record last verified: 2008-01

Locations

DE (1)