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

NCT00184730 | Completed Phase 3

• 2 other identifiers: GHLIQUID-1650JapicCTI-050134
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519) until hGH products have been approved for GHDA in Japan.

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (2)

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

  at the end of treatment

• GH-related laboratory parameters (IGF-I, IGF-I SDS, IGFBP-3, IGFBP-3 SDS and IGF-I / IGFBP-3 molar ratio)

  at the end of treatment

Secondary Outcomes (3)

• Adverse events

• FPG, insulin, and HbA1C

• Clinical laboratory tests

Interventions

somatropin DRUG

Eligibility Criteria

• Age: 19 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who completed GHLiquid-1519.
• 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 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: November 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: November 17, 2016

Record last verified: 2016-11

Locations

JP (1)