Growth Hormone Deficiency in Adults (GHDA) | NCT00519558

Studies
Growth Hormone Deficiency in Adults (GHDA)

NCT00519558

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 28, 2017Actual

Enrollment

121Actual

Phase

Phase 3

Conditions

Growth Hormone Disorder
Adult Growth Hormone Deficiency

Interventions

somatropin

Countries

Japan

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
JapicCTI-R070007	Registry Identifier	JAPIC

Status Module

Record Verification Date

Feb 2017

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

May 31, 2003Actual

Primary Completion Date

Jan 24, 2005Actual

Completion Date

Jan 24, 2005Actual

First Submitted Date

Aug 20, 2007

First Submission Date that Met QC Criteria

Aug 21, 2007

First Posted Date

Aug 22, 2007Estimated

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

Feb 27, 2017

Last Update Posted Date

Feb 28, 2017Actual

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

This trial is conducted in Japan. The aim of this trial is to demonstrate superiority of the effect of NN-220 compared with that of placebo as assessed by the change in percent in truncal fat (kg) from baseline to 24 weeks' treatment (end of treatment) in patients with Growth Hormone Deficiency in Adults (GHDA).

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Name	Type	Description	Arm Group Labels	Other Names
somatropin	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change in truncal fat (kg) from baseline		at 24 weeks (end of treatment)

Secondary Outcomes

Measure	Description	Time Frame
Change in total body fat, total LBM, etc. from baseline to 24 weeks
Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with diagnosed GHD
If the subject has a history of treatment of treatment for a tumour of pituitary or peripheral site, two years or more must have passed since completion of surgery, radiotherapy or other treatment, and recurrence of the underlying disease to be excluded
Appropriate replacement therapy has been administered for more than 24 weeks for the treatment of other pituitary hormone deficiencies

Exclusion Criteria:

Subject with a history of acromegaly
Subject with diabetes mellitus
Subject suffering from malignancy
Several medical conditions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Tokyo		1000005	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18395480	Derived	Chihara K, Kato Y, Shimatsu A, Tanaka T, Kohno H. Efficacy and safety of individualized growth hormone treatment in adult Japanese patients with growth hormone deficiency. Growth Horm IGF Res. 2008 Oct;18(5):394-403. doi: 10.1016/j.ghir.2008.02.002. Epub 2008 Apr 18.

ID	Term
D004392	Dwarfism
D001848	Bone Diseases, Developmental
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

ID	Term
D013006	Growth Hormone
D010908	Pituitary Hormones, Anterior
D010907	Pituitary Hormones
D036361	Peptide Hormones