Efficacy of Somatropin in Adult Patients With Isolated Growth Hormone Deficiency

NCT00630487 | Terminated Phase 3 Results

• 1 other identifier: A6281282
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The study will investigate the effect on growth hormone replacement in patients with isolated growth hormone deficiency on body composition, especially visceral fat mass.

Conditions

Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

• Change of Visceral Fat Mass Assessed by Magnetic Resonance Imaging Scanning (MRI)

  Fat measurements carried out with the subjects lying in a supine position in a MRI scanner. Measurements of regional body fat obtained between the level of the coccygeal bone and the 2nd or 3rd lumbar vertebra.

  Baseline, 52 weeks

Secondary Outcomes (14)

• Change in Visceral Fat Mass in Subgroups

  Baseline, 52 weeks, 78 weeks

• Change From Baseline in Anthropometric Parameters (Height)

  Baseline, 52 weeks, 78 weeks

• Change From Baseline in Anthropometric Parameters (Weight)

  Baseline, 52 weeks, 78 weeks

• Change From Baseline in Anthropometric Parameters (Waist Circumference)

  Baseline, 52 weeks, 78 weeks

• Change From Baseline in Alertness (Testbatterie Zur Aufmerksamkeitsprüfung [TAP]) and Memory (Auditory Verbal Learning Test [AVLT])

  Baseline, Week 52, Week 78

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Verum

ACTIVE COMPARATOR

Drug: Somatropin

Interventions

Placebo DRUG

Patients of Placebo Group will be treated with placebo sub-cutaneous in the same way as Somatropin during the double blind treatment phase. To maintain blind subject will be measured in the same way as the treatment group for IGF-I- Levels. Central lab will randomize placebo patients to dose change or maintenance of dose. This will ensure continued blinding of the study to patients and personnel.

Placebo

Somatropin DRUG

Fixed doses for patients: MALE: \< 45y 0,4 mg, \> 45y 0,2mg FEMALE: \< 45y 0,5mg, \>45y 0,3mg. for the first 4 weeks half of the dose will be given. After that dose will be increased to the targeted maintenance dose according to IGF-I Levels +/- 2 SD of age adjusted reference range. In case of side effects dosage will remain on half-dose (during the first 4 weeks) or reduced to half dose (after the first 4 weeks). At week 52 patients have the opportunity to switch to open label study restarting with half the given fixed dose which will be adjusted to full dose after 4 weeks.

Verum

Eligibility Criteria

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

You may qualify if:

• Males and females between 18 and 65 years of age
• Isolated growth hormone deficiency

You may not qualify if:

• Isolated growth hormone deficiency by childhood onset
• Diabetes mellitus type 1 or 2

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Bad Aibling, 83043, Germany

Location

Pfizer Investigational Site

München, 80804, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 28, 2008
• First Posted: March 7, 2008
• Study Start: May 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 4, 2013
• Results First Posted: January 27, 2011

Record last verified: 2013-02

Locations

DE (2)