Growth Hormone Deficiency in Adults (GHDA)

NCT00519558 | Completed Phase 3

• 2 other identifiers: GHLIQUID-1518JapicCTI-R070007
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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).

Conditions

Growth Hormone Disorder; Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Percent change in truncal fat (kg) from baseline

  at 24 weeks (end of treatment)

Secondary Outcomes (6)

• 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)

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

• Adverse events

• Clinical laboratory tests

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 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

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2007
• First Posted: August 22, 2007
• Study Start: May 31, 2003
• Primary Completion: January 24, 2005
• Study Completion: January 24, 2005
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

JP (1)