Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

NCTNCT01859949 (opens ClinicalTrials.gov in a new tab)Other idGENASG-0021-007Other idA6281225Other id2015-004552-21Other id2015
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
62 participants (actual)
Sponsor
Pfizer · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Japan

Start
Oct 2002
Primary completion
Aug 2015
Completion
Aug 2015
First posted
22 May 2013 (estimated)
Last update posted
3 May 2016 (estimated)
Conditions
Short Stature Born Small for Gestational Age (SGA)

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200520102015
  1. Ph 4

    Long Term Study of Genotropin (Somatropin) for Short Children Born Small for Gestational Age (SGA)

    NCT01859949

    Oct 2002 to Aug 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To assess the long-term safety of Genotropin(somatropin) on Small for Gestational Age (SGA) without epiphyseal closing.

Interventions

  • Genotropin (somatropin)Drug

Arms1

  • Experimental

    Genotropin (somatropin)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame · Month 12 (at the end of previous study) to 156

Secondary outcomes(5)

  1. Height Velocity Standard Deviation Score (SDS) for Chronological Age

    Time frame · Month 12 (at the end of previous study) to 156

    Registry description

    Height velocity is the yearly height gain. Height velocity SDS is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values of the participants age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.

  2. Height Velocity

    Time frame · Month 12 (at the end of previous study) to 156

    Registry description

    Height velocity is the yearly height gain

  3. Height SDS for Chronological Age

    Time frame · Month 12 (at the end of previous study) to 156

    Registry description

    Height SDS is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values on the participant age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.

  4. Height Velocity SDS for Bone Age

    Time frame · Month 12 (at the end of previous study) to 156

    Registry description

    To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height velocity is the yearly height gain. Height velocity SDS for bone age is calculated as following formula; Height velocity SDS = (height velocity - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.

  5. Height SDS for Bone Age

    Time frame · Month 12 (at the end of previous study) to 156

    Registry description

    To measure bone age, X-ray images of the left hand were centrally assessed by an independent specialist using the Tanner-Whitehouse 2 (RUS) method standardized for Japanese children. Height SDS for bone age is calculated as following formula; Height SDS = (height - mean) / standard deviation, where mean and standard deviation were based on standard Japanese values corresponding to bone age and gender. The scores were centred around zero. Negative score indicated a participant was smaller for their age/gender.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Month 12 (at the end of previous study) to 156

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

GroupValue (participant)
Dose-Increasing Group27
Dose-Remaining Group31
Secondary and other outcome results(5)
Secondary outcomeMean· Month 12 (at the end of previous study) to 156

Height Velocity Standard Deviation Score (SDS) for Chronological Age

GroupValue (SDS)Spread
Dose-Increasing Group2.7821.978
Dose-Remaining Group2.5951.731
Secondary outcomeMean· Month 12 (at the end of previous study) to 156

Height Velocity

GroupValue (cm/year)Spread
Dose-Increasing Group7.831.33
Dose-Remaining Group7.701.19
Secondary outcomeMean· Month 12 (at the end of previous study) to 156

Height SDS for Chronological Age

GroupValue (SDS)Spread
Dose-Increasing Group-2.530.92
Dose-Remaining Group-2.170.96
Secondary outcomeMean· Month 12 (at the end of previous study) to 156

Height Velocity SDS for Bone Age

GroupValue (SDS)Spread
Dose-Increasing Group2.5862.268
Dose-Remaining Group2.4611.990
Secondary outcomeMean· Month 12 (at the end of previous study) to 156

Height SDS for Bone Age

GroupValue (SDS)Spread
Dose-Increasing Group-1.191.20
Dose-Remaining Group-0.681.54

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Dose-Increasing GroupParticipants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day–10 / 2927 / 29
Dose-Remainig GroupParticipants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study–5 / 3231 / 32

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 4 Years up to 8 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: Children with short stature due to SGA who received treatment in the study GENASG-0021-002. Exclusion Criteria: * Children who have any chronic disease requiring treatment with steroid hormone that may affect growth promotion including estrogen, androgen, anabolic hormone, and corticosteroids (except those for external use), and have received the treatment. * Children who have received radiotherapy or chemotherapy. * Children who have serious cardiac disease, renal disease, or hepatic disease. * Children who have diabetes mellitus with a manifestation of abnormal glucose metabolism. * Children who have serious chronic disease. * Children who have malignant tumor. * Children who are allergic to m-cresol.

PepBank is a research reference. Talk to a doctor before you use any peptide.