- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00793325
Long Term Use of Somatropin in Patients Small for Gestational Age
Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Somatropin (Genotropin®).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Somatropin
Patients administered Somatropin.
|
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."
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment Related Adverse Events.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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).
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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.
Time Frame: Up to 3 years
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A6281292
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Small for Gestational Age
-
Tel-Aviv Sourasky Medical CenterUnknownSmall for Gestational Age Infants | Appropriate for Gestational Age InfantsIsrael
-
Société des Produits Nestlé (SPN)CompletedSmall for Gestational Age (SGA) Infants | Appropriate for Gestational Age (AGA) InfantsIndia
-
SandozCompletedSmall for Gestational AgeBelgium, Czechia, Georgia, Hungary, Poland, Romania, Germany
-
GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsUnknownSmall for Gestational Age InfantChina
-
PfizerCompletedSmall For Gestational Age (SGA)Spain
-
Eli Lilly and CompanyCompletedInfant, Small for Gestational AgeGermany
-
Dong-A ST Co., Ltd.CompletedInfant, Small for Gestational AgeKorea, Republic of
-
PfizerCompletedInfant, Small for Gestational AgeCzech Republic, Spain, Sweden, Netherlands, Belgium, France, Germany, Italy, Switzerland
-
GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsCompletedSmall for Gestational Age InfantChina
-
Merck KGaA, Darmstadt, GermanyMerck Serono S.P.A., ItalyTerminated
Clinical Trials on Somatropin
-
Xiamen Amoytop Biotech Co., Ltd.Peking Union Medical College HospitalCompleted
-
PfizerActive, not recruitingPrader-Willi SyndromeJapan
-
GeneScience Pharmaceuticals Co., Ltd.The First Affiliated Hospital with Nanjing Medical University; Tongji Hospital and other collaboratorsActive, not recruiting
-
PfizerCompletedGrowth Hormone DeficiencyFrance
-
Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden
-
Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderJapan
-
LG ChemCompletedBioavailability, Safety and Tolerability Among Different Eutropin Formulations in Healthy VolunteersKorea, Republic of
-
Novo Nordisk A/SCompletedFoetal Growth Problem | Small for Gestational AgeJapan
-
Novo Nordisk A/SCompletedAchondroplasia | Genetic DisorderJapan
-
Novo Nordisk A/SCompletedNoonan Syndrome | Genetic DisorderSweden