AcromegalyPhase 4NCT00595140
Acute Application of Pegvisomant and Octreotide in Acromegaly
A Phase 4 study testing pegvisomant, combination with somatostatin analogue octreotide and combination with dopamine agonist cabergoline in people with Acromegaly, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- pegvisomant, combination with somatostatin analogue octreotide and combination with dopamine agonist cabergoline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Mar 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medizinische Klinik - Innenstadt of the University of Munich
Munich, 80336
About this study
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
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
- Being tested
- pegvisomant, combination with somatostatin analogue octreotide, combination with dopamine agonist cabergoline
- Keywords
- Acromegaly,, growth hormone receptor antagonist,, somatostatin analogue,, combined medical treatment,, acute effect,, endogenous GH
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegvisomantDrug
Also called 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
growth hormone receptor antagonist pegvisomant in patients´ individual dose
combination with somatostatin analogue octreotideDrug
Also called Octreotide: Sandostatin 100µg: MA number 29423.01.00
s.c., 100µg, one time
combination with dopamine agonist cabergolineDrug
Also called Cabergoline: Dostinex 0.5mg: MA number 32411.00.00
oral, 0.5mg, one time
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | patients with acromegaly on stable pegvisomant therapy Receives: Drug: pegvisomant |
| 2 | Active comparator | Patients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg Receives: Drug: combination with somatostatin analogue octreotide |
| 3 | Active comparator | Patients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally Receives: Drug: combination with dopamine agonist cabergoline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The decrease of endogenous growth hormone
Measured: 6 or 9 hours
Secondary outcomes (1)
The course of glucose, insulin and pegvisomant during the profiles
Measured: 6 or 9 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Jochen Schopohl, MD, Principal investigator, Medizinische Klinik - Innenstadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595140
- Sponsor's protocol ID
- EudraCT-Nr. 2007-005585-12
- Other IDs
- EudraCT-Nr. 2007-005585-12
- Status last verified
- Jan 2008
- First submitted
- 7 Jan 2008
- Last updated
- 1 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00595140
- Acronym / sponsor ID
- EudraCT-Nr. 2007-005585-12
- Conditions
- Acromegaly
- Keywords
- Acromegaly,, growth hormone receptor antagonist,, somatostatin analogue,, combined medical treatment,, acute effect,, endogenous GH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Drug: pegvisomantpatients with acromegaly on stable pegvisomant therapy |
| 2 | Active comparator | Drug: combination with somatostatin analogue octreotidePatients with acromegaly on stable pegvisomant therapy and additional application of octreotide 100µg |
| 3 | Active comparator | Drug: combination with dopamine agonist cabergolinePatients with acromegaly on stable pegvisomant therapy and additional application of cabergoline 0.5mg orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegvisomantAlso: Pegvisomant:, SOMAVERT 10 mg: EU/1/02/240/001, SOMAVERT 15 mg: EU/1/02/240/002, SOMAVERT 20 mg: EU/1/02/240/003growth hormone receptor antagonist pegvisomant in patients´ individual dose | Drug | 1 |
| combination with somatostatin analogue octreotideAlso: Octreotide: Sandostatin 100µg: MA number 29423.01.00s.c., 100µg, one time | Drug | 2 |
| combination with dopamine agonist cabergolineAlso: Cabergoline: Dostinex 0.5mg: MA number 32411.00.00oral, 0.5mg, one time | Drug | 3 |
Primary outcome
The decrease of endogenous growth hormone
Time frame: 6 or 9 hours
1 secondary outcome
The course of glucose, insulin and pegvisomant during the profiles
Time frame: 6 or 9 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2008.
Related trials for Acromegaly
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RecruitingObservational study
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jochen Schopohl, MD principal investigator
Medizinische Klinik - Innenstadt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pegvisomant, combination with somatostatin analogue octreotide and combination with dopamine agonist cabergoline in people with Acromegaly, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decrease of endogenous growth hormone (time frame: 6 or 9 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2008.