Co-treatment With Pegvisomant and a Somatostatin Analogue... | NCT00652379

Studies
Co-treatment With Pegvisomant and a Somatostatin Analogue (SA) in SA-responsive Acromegalic Patients

NCT00652379

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jan 26, 2012Estimated

Enrollment

18Actual

Phase

Not Applicable

Conditions

Acromegaly
Insulin Resistance
Impaired Glucose Tolerance

Interventions

Pegvisomant
Somatostatin analog (lanreotide or octreotide)

Countries

Denmark

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
2007-005244-25	EudraCT Number

Status Module

Record Verification Date

Jan 2012

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

Jun 2008

Primary Completion Date

Nov 2009Actual

Completion Date

May 2011Actual

First Submitted Date

Mar 26, 2008

First Submission Date that Met QC Criteria

Mar 31, 2008

First Posted Date

Apr 3, 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

Jan 25, 2012

Last Update Posted Date

Jan 26, 2012Estimated

Name	Class
Aarhus University Hospital Skejby	OTHER
Aarhus University Hospital	OTHER
The Research Council for Health and Disease, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 this study is to investigate if co-treatment of acromegalic patients, who beforehand are considered well-controlled on SA monotherapy, with pegvisomant and SA will improve insulin sensitivity and glucose tolerance, and if these effects of co-treatment can be obtained at a neutral cost as compared to SA mono therapy.

Second to investigate body composition, substrate metabolism, symptoms, intrahepatic and intramyocellular fat.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Co-treatment with Pegvisomant (15-30 mg twice a week) and a 50 percent reduced somatostatin-analog dose	Drug: Pegvisomant Drug: Somatostatin analog (lanreotide or octreotide)
2	Active Comparator	Somatostatin analog, unaltered dosage	Drug: Somatostatin analog (lanreotide or octreotide)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pegvisomant	Drug	Pegvisomant s.c 15-30 mg 2 times a week	1	Somavert

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin sensitivity		0 and after 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Glucose tolerance		0 and after 24 weeks
Symptoms, QoL questionaire		0, 12 and 24 weeks
Intrahepatic and intramyocellular fat

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18
Diagnosed with acromegaly
Safe anticonceptive for fertile women
Well controlled on somatostatin analog (a serum IGF-I within normal range a nadir GH < 0.5 µg/l.)

Exclusion Criteria:

Pregnancy
Liver disease
Diabetes mellitus type I
Magnetic or electronic implants

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
Jens Otto L. Jørgensen, MD Professor	Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Endocrinology, Aarhus University Hospital		Aarhus C	Aarhus	8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000172	Acromegaly
D007333	Insulin Resistance
D018149	Glucose Intolerance

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
D013004	Somatostatin
C060347	lanreotide
D015282	Octreotide

Ancestor Terms

ID	Term
D010905	Pituitary Hormone Release Inhibiting Hormones
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones

Browse Leaves

Not provided

Browse Branches

Not provided