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

NCT00184743 | Completed Phase 3

• 2 other identifiers: GHLIQUID-1519JapicCTI-050133
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Percent change in truncal fat (kg)

  from the baseline to the end of treatment

Secondary Outcomes (6)

• Adverse events

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

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

• FPG, insulin, and HbA1C

• IGF-I SDS, IGFBP-3 SDS, and IGF-I/IGFBP-3 molar ratio

Interventions

somatropin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Related Publications (1)

• 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.

  PMID: 18395480 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 6, 2003
• Primary Completion: December 28, 2005
• Study Completion: December 28, 2005
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

JP (1)