Acute Application of Pegvisomant and Octreotide in Acrome... | NCT00595140

Studies
Acute Application of Pegvisomant and Octreotide in Acromegaly

NCT00595140

Sponsor

Ludwig-Maximilians - University of Munich

Status

Completed

Last Update Posted

Apr 1, 2008Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Acromegaly

Interventions

pegvisomant
combination with somatostatin analogue octreotide
combination with dopamine agonist cabergoline

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT-Nr. 2007-005585-12

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Jan 7, 2008

First Submission Date that Met QC Criteria

Jan 7, 2008

First Posted Date

Jan 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2008

Last Update Posted Date

Apr 1, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
pegvisomant	Drug	growth hormone receptor antagonist pegvisomant in patients´ individual dose	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The decrease of endogenous growth hormone		6 or 9 hours

Secondary Outcomes

Measure	Description	Time Frame
The course of glucose, insulin and pegvisomant during the profiles		6 or 9 hours

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jochen Schopohl, MD	Medizinische Klinik - Innenstadt	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medizinische Klinik - Innenstadt of the University of Munich		Munich		80336	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000172	Acromegaly

Ancestor Terms

ID	Term
D001849	Bone Diseases, Endocrine
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006964	Hyperpituitarism

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C406545	pegvisomant

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided