You are here

Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

Last updated on November 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Berlin, , 13353 Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Therapy, Small for Gestational Age Infant
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-10 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of
age.

- Birth length- and/or birth weight-SDS adjusted to gestational age al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).

- Current height-SDS below -1 (Hermanussen and Cole 2003).

- Growth velocity SDS

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

- Severe SGA (birth weight or length features.

- Severe pre-maturity (GA

- Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis
(NEC), respiratory distress syndrome, if associated with long-term sequelae (like
short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).

- Inability to perform one- or two leg jumps from a standing position.

- Prior GH treatment.

NCT00625872
Pfizer
Terminated
Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy

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]

call now

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.
Descriptive Information
Brief Title  ICMJE Neuromuscular Changes In Small For Gestational Age Children During Somatropin Therapy
Official Title  ICMJE Neuromuscular Changes In Small For Gestational Age (SGA) Children During Somatropin Therapy - A Prospective Randomized, Controlled, Open-Label Multicenter Trial
Brief SummaryThe planned study focuses on the effect of a one year Somatropin treatment (0.035 mg/kg/d or 0.067 mg/kg/d) in short children born SGA on neuromuscular function and cognitive performance.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Hormone Therapy
  • Infant, Small for Gestational Age
Intervention  ICMJE Drug: Somatropin
Patients will be randomized at baseline in a 1:1 ratio into treatment group or control group. After six months the control group will undergo GH therapy with a higher dose of 0.067 mg/kg/day, too. All patients are treated with growth hormone for 12 months.
Study Arms  ICMJE
  • Active Comparator: Treatment Group
    Somatropin for 12 months
    Intervention: Drug: Somatropin
  • Control Group
    In the first 6 months no intervention, afterwards Somatropin for 12 months
    Intervention: Drug: Somatropin
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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 27, 2012)
23
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2008)
88
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion DateMarch 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pre-pubertal boys between 6 and 10 years of age or girls between 6 and 9 years of age.
  • Birth length- and/or birth weight-SDS adjusted to gestational age < -2.0 (Voigt et al. 2002, Voigt et al. 2006 or Lawrence et al. 1989).
  • Current height-SDS < -2.5 (Brandt/Reinken 1992) and parental adjusted height-SDS below -1 (Hermanussen and Cole 2003).
  • Growth velocity SDS < 0 during the last year before inclusion (Brandt/Reinken 1988).

Exclusion Criteria:

  • Severe SGA (birth weight or length < -4 SD) and clinically relevant dysmorphic features.
  • Severe pre-maturity (GA < 32 weeks of gestation).
  • Severe perinatal complications like asphyxia, sepsis, necrotizing enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, bronchopulmonary dysplasia (BPD), cerebral palsy etc).
  • Inability to perform one- or two leg jumps from a standing position.
  • Prior GH treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 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 NCT00625872
Other Study ID Numbers  ICMJE A6281283
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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