Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

NCT00174460 | Completed Phase 2 Results

• 1 other identifier: A6281273
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 8

Brief Summary

Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.

Conditions

Growth Hormone Therapy; Infant, Very Low Birth Weight

Outcome Measures

Primary Outcomes (2)

• Change in Height Standard Deviation Score (SDS) After 1 Year

  Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).

  Baseline to 1 year (Month 12)

• Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year

  Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).

  Baseline to 1 year (Month 12)

Secondary Outcomes (21)

• Change From Baseline in Growth Velocity After 1 Year and After 2 Years

  Baseline, Month 12, Month 24

• Change From Baseline in Growth Velocity SDS After 2 Years

  Baseline, Month 24

• Change From Baseline in Height After 1 Year and After 2 Years

  Baseline, Month 12, Month 24

• Change From Baseline in Height SDS After 2 Years

  Baseline, Month 24

• Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps

  Baseline, Month 12, Month 24

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

Drug: Somatropin; Other: Control Arm

Control Arm

NO INTERVENTION

Interventions

Somatropin DRUG

Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. Children randomized to the control group will get the possibility to continue treatment for a further year. The study will end after 2 and 3 years of observation, respectively.

Treatment Arm

Control Arm OTHER

Controlled, prospective, randomized, multicenter study with an untreated (control) group during the first year. The children will be randomized into treatment or untreated (control) group. After one year the control group will undergo GH-therapy, too. The study will end after 2 and 3 years of observation, respectively. Children randomized to the control group will get the possibility to continue treatment for a further year.

Treatment Arm

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
• Girls: Tanner stage 1 breast development
• Boys: Testis volume \<= 3ml
• Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
• (In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)
• Height \<=-2 SD for chronological age (Brandt/Reinken).
• Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).
• Premature born defined as \<=1500 g birth weight.
• GH sufficiency (GH level \> 7 ug/l following any routine GH stimulation test).
• Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the trial:
• Other endocrine diseases except for well substituted hypothyroidism.
• Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
• Positive GAD and IA-2 antibodies (for type 1 diabetes).
• History of malignancy
• Children who meet all of the following 4 criteria:
• actual body height \< -2,5 SDS (Brandt/Reinken) and parent adjusted target height \< -1 SDS (Hermanussen and Cole, 2003)
• length and/or body weight retardations adjusted to gestational age at birth \< -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
• children with chronological age \> = 4 years and
• Chromosomal aberrations or syndromes.
• Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
• Severe hemiparesis and severe CNS defects
• Retinopathia \> third degree or laser treatment as newborns.
• Participation in any other clinical trial during active treatment phase.
• Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

Pfizer Investigational Site

Chemnitz, 09009, Germany

Location

Pfizer Investigational Site

Cologne, 50937, Germany

Location

Pfizer Investigational Site

Erlangen, 91054, Germany

Location

Pfizer Investigational Site

Freiburg im Breisgau, 79106, Germany

Location

Pfizer Investigational Site

Heidelberg, 69120, Germany

Location

Pfizer Investigational Site

Homburg, 66424, Germany

Location

Pfizer Investigational Site

Leipzig, 04103, Germany

Location

Pfizer Investigational Site

Tübingen, 72076, Germany

Location

Related Links

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

MeSH Terms

Interventions

Human Growth Hormone

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

Limitations and Caveats

Result values for the primary outcome measures were revised at the final analysis due to programmatic corrections: age rounded up if \>6 months past last birthday. Height and height SDS not rounded for final analysis; rounded only for the reports.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: August 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2010
• Last Updated: April 5, 2017
• Results First Posted: May 12, 2009

Record last verified: 2017-03

Locations

DE (8)