Special Investigation Of Genotropin Long Follow-Up For Patients With A Small For Gestational Age "Scoped for Japanese"

NCT01897766 | Completed Results

• 1 other identifier: A6281314
• Study Type: observational
• Target: 482
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this surveillance is to collect Safety and Effectiveness information for Long term Use of Somatropin for Patients with a Small for Gestational Age (SGA).

Conditions

Small for Gestational Age (SGA)

Keywords

Genotropin; Somatropin; Long Term Follow-Up; Special Investigation; Small for Gestational Age; SGA

Outcome Measures

Primary Outcomes (18)

• Number of Participants With Adverse Drug Reaction (ADR)

  An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Genotropin in a participant who received Genotropin. A serious ADR (SADR) was an ADR resulting in any of the following out comes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Genotropin was assessed by the physician.

  Approximately 11.58 years

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline At Year 1

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 1

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 2

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 3

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 4

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 5

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 6

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 7

• Change in Height Velocity Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10

  Change in height Velocity SD score from baseline was calculated. Height Velocity SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 10

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 1

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 1

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 2

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 2

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 3

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 3

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 4

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 4

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 5

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 5

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 6

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 6

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 7

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 7

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 9

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 9

• Change in Height Standard Deviation (SD) Score for Chronological Age From Baseline at Year 10

  Change in height SD score from baseline was calculated. Height SD score = (Height - Standard height for chronological age of gender) / SD. An SD score indicates how far a participant's score deviates from the mean of the reference population; an SD score higher than the mean gives a positive SD score whereas an SD score lower than the mean gives a negative SD score. SD score indicates how similar participant was to reference population.

  Baseline, Year 10

Secondary Outcomes (2)

• Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height

  Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years

• Change in Height Standard Deviation (SD) Score at Puberty and at Near Final Height in Participants Who Reached Near Final Height From Baseline

  Baseline, At Puberty, At Near Final Height within the span of approximately maximum of 11.58 years

Study Arms (1)

Somatropin

Patients administered Somatropin.

Drug: Somatropin

Interventions

Somatropin DRUG

0.23 mg to 0.48 mg/kg/week

Also known as: Genotropin

Somatropin

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

* A patients who is diagnosed for SGA. (SGA is defined as birth weight and/or length at least 2 standard deviations (SDs) below the mean for gestational age (\<or=-2 SD)). * A patient who is SGA and older than 3 years. * A patient who has persistent short stature (i.e., remaining at least 2.5 SD below the mean for chronologic age).

You may qualify if:

• A patient who was administered Somatropin (Genotropin).

You may not qualify if:

• N/A.

Sponsors & Collaborators

• Pfizer: lead

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

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: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2013
• First Posted: July 12, 2013
• Study Start: September 5, 2013
• Primary Completion: February 28, 2017
• Study Completion: June 7, 2017
• Last Updated: September 25, 2023
• Results First Posted: February 11, 2020

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share