Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

NCT00174460

Last updated date
Study Location
Pfizer Investigational Site
Chemnitz, , 09009, Germany
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Therapy, Very Low Birth Weight Infant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
4-10 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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


- growth velocity < 0 SDS during the last year before inclusion.


- 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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Growth Hormone Therapy, Very Low Birth Weight InfantSomatropin Therapy In Children Born Preterm But Appropriate For Gestational Age NCT00174460
  1. Chemnitz,
  2. Erlangen,
  3. Freiburg,
  4. Heidelberg,
  5. Homburg,
  6. Koeln,
  7. Leipzig,
  8. Tuebingen,
ALL GENDERS
4 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age
Official Title  ICMJE Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Hormone Therapy
  • Infant, Very Low Birth Weight
Intervention  ICMJE
  • Drug: Somatropin
    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.
  • Other: Control Arm
    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.
Study Arms  ICMJE
  • Active Comparator: Treatment Arm
    Interventions:
    • Drug: Somatropin
    • Other: Control Arm
  • No Intervention: Control Arm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2008)
33
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

  • 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.

Exclusion Criteria:

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
  • growth velocity < 0 SDS during the last year before inclusion.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 4 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174460
Other Study ID Numbers  ICMJE A6281273
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP