Back to resultsAcute Application of Pegvisomant and Octreotide in Acromegaly
Primary Purpose
Acromegaly
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
pegvisomant
combination with somatostatin analogue octreotide
combination with dopamine agonist cabergoline
Sponsored by
About this trial
This is an interventional treatment trial for Acromegaly focused on measuring Acromegaly,, growth hormone receptor antagonist,, somatostatin analogue,, combined medical treatment,, acute effect,, endogenous GH
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Medizinische Klinik - Innenstadt of the University of Munich
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
patients with acromegaly on stable pegvisomant therapy
Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally
Outcomes
Primary Outcome Measures
The decrease of endogenous growth hormone
Secondary Outcome Measures
The course of glucose, insulin and pegvisomant during the profiles
Full Information
NCT ID
NCT00595140
First Posted
January 7, 2008
Last Updated
March 31, 2008
Sponsor
Ludwig-Maximilians - University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT00595140
Brief Title
Acute Application of Pegvisomant and Octreotide in Acromegaly
Official Title
The Effect of Acute Application of Pegvisomant Alone and in Combination With Octreotide on Endogenous GH Levels During a 6 Hour Test in Patients With Acromegaly on Constant Pegvisomant Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ludwig-Maximilians - University of Munich
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly
Keywords
Acromegaly,, growth hormone receptor antagonist,, somatostatin analogue,, combined medical treatment,, acute effect,, endogenous GH
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
patients with acromegaly on stable pegvisomant therapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg
Arm Title
3
Arm Type
Active Comparator
Arm Description
Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally
Intervention Type
Drug
Intervention Name(s)
pegvisomant
Other Intervention Name(s)
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
Intervention Description
growth hormone receptor antagonist pegvisomant in patients´ individual dose
Intervention Type
Drug
Intervention Name(s)
combination with somatostatin analogue octreotide
Other Intervention Name(s)
Octreotide: Sandostatin 100µg: MA number 29423.01.00
Intervention Description
s.c., 100µg, one time
Intervention Type
Drug
Intervention Name(s)
combination with dopamine agonist cabergoline
Other Intervention Name(s)
Cabergoline: Dostinex 0.5mg: MA number 32411.00.00
Intervention Description
oral, 0.5mg, one time
Primary Outcome Measure Information:
Title
The decrease of endogenous growth hormone
Time Frame
6 or 9 hours
Secondary Outcome Measure Information:
Title
The course of glucose, insulin and pegvisomant during the profiles
Time Frame
6 or 9 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jochen Schopohl, MD
Organizational Affiliation
Medizinische Klinik - Innenstadt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Klinik - Innenstadt of the University of Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Acute Application of Pegvisomant and Octreotide in Acromegaly
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