Long Term Use of Somatropin in Patients Small for Gestational Age

NCT00793325 | Completed Results

• 1 other identifier: A6281292
• Study Type: observational
• Target: 920
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

Conditions

Small for Gestational Age

Outcome Measures

Primary Outcomes (12)

• Number of Participants With Treatment Related Adverse Events.

  Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin.

  Up to 3 years

• Number of Unlisted Treatment Related Adverse Events According to Japanese Package Insert.

  Adverse events mean all unfavorable events that occur in participants after administration of somatropin, irrespective of causal relationship to somatropin (including clinically problematic abnormal changes in laboratory test values). Treatment related adverse events were evaluated in company with the causal relationship to somatropin. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction according to Japanese package insert.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin: <15 Years of Age vs. >=15 Years of Age.

  To determine whether age is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin by Gender.

  To determine whether gender is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin Based on SGA Severity.

  To determine whether severity of SGA is a significant risk factor in the frequency of treatment related adverse events. The severity of SGA was comprehensively evaluated on the basis of information including height and weight at birth and height measured one year before the start of administration.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin: With Past History of Any Disease vs. Without Past History of Any Disease.

  To determine whether past history of any disease is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin: With Complications vs. Without Complications

  To determine whether having complication(s) is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin: With Hepatic Function Disorder vs. Without Hepatic Function Disorder.

  To determine whether hepatic function disorder is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin: With Renal Impairment vs. Without Renal Impairment.

  To determine whether renal impairment is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Number of Participants With Treatment Related Adverse Events of Somatropin: With Concomitant Drug(s) vs. Without Concomitant Drug(s).

  To determine whether taking concomitant drug(s) is a significant risk factor in the frequency of treatment related adverse events.

  Up to 3 years

• Change in the Growth Rate Standard Deviation (SD) Score for Calendar Age.

  Growth rate SD score = (Growth rate - Average growth rate for calendar age of gender) / SD score for growth rate for each calendar age of gender). 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. In addition, when the bone age was described, it was to be read as the calendar age for men who were 11 years or older and women who were 9 years or older, as necessary.

  Up to 3 years

• Change in Height SD Score for Calendar Age.

  The change in height standard SD for calendar age = (Height SD score for each calendar age - Height SD score for calendar age of the previous year) / (the date on which the height was measured - the date of the previous year on which the height was measured) × 365.25.

  Up to 3 years

Study Arms (1)

Somatropin

Patients administered Somatropin.

Drug: Somatropin

Interventions

Somatropin DRUG

Genotropin® 5.3mg, Genotropin®inj.12mg, Genotropin®MiniQuick s.c. inj.0.6mg・1.0mg・1.4mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " Normally, the dosage is 0.021 mg/kg/week as somatropin (genetical recombination) in 6-7 divided doses by s.c. route. If efficacy is insufficient, the dose may be increased up to 0.47 mg/kg/week in 6-7 divided doses in a week by s.c. route."

Also known as: Genotropin

Somatropin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).

You may qualify if:

• Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.

You may not qualify if:

• Patients not administered Somatropin (Genotropin®).

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: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2008
• First Posted: November 19, 2008
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 6, 2014
• Results First Posted: February 6, 2014

Record last verified: 2013-12