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CompletedNCT00184743Updated Feb 28, 2017

Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)

A Phase 3 interventional study of somatropin in Growth Hormone Disorder and Adult Growth Hormone Deficiency, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-02-28.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2003, registered Sep 2005).
Phase
Phase 3
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This trial is conducted in Japan. To investigate the long-term efficacy as assessed by change in fat mass and safety after 48 weeks of treatment of Growth Hormone in adults with Growth Hormone Deficiency, comparing two different treatment regiments.

02

Conditions studied

  • Growth Hormone Disorder
  • Adult Growth Hormone Deficiency
03

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 112 is above the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects who completed GHLiquid-1518.
  • If the subject has a history of treatment for a tumor of pituitary or peripheral site, two years or more have to be 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

Exclusion Criteria:

  • Subject with a history of acromegaly.
  • Subject with diabetes mellitus.
  • Subject suffering from malignancy.
  • Several medical conditions
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (actual)

Interventions

  • Drugsomatropin
06

What researchers measure

Primary outcomes

  1. Percent change in truncal fat (kg)

    Time frame: from the baseline to the end of treatment

Secondary outcomes

  1. Adverse events

  2. Change in Total body fat, Total LBM, etc. from the baseline to the end of treatment

  3. Lipid-related laboratory tests (total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglyceride)

  4. FPG, insulin, and HbA1C

  5. IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio

  6. Clinical laboratory tests

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Tokyo, 1000005, Japan
08

References and documents

Publications

  • 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. PubMed 18395480 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00184743
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
Dec 6, 2003
Primary completion
Dec 28, 2005
Completion
Dec 28, 2005
Last update
Feb 28, 2017

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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