Long Term Use of Somatropin in Patients Small for Gestational Age
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Small for Gestational Age |
Drug: Somatropin |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan) |
- Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]
- The incidence of adverse drug reactions in this surveillance. [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]
- Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 3 years maximum ] [ Designated as safety issue: Yes ]
| Enrollment: | 920 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Somatropin
Patients administered Somatropin.
|
Drug: 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 Name: Genotropin
|
Detailed Description:
All the patients whom an investigator prescribes the first Genotropin® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).
Inclusion Criteria:
- Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Somatropin (Genotropin®).
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00793325 History of Changes |
| Other Study ID Numbers: | A6281292 |
| Study First Received: | November 17, 2008 |
| Last Updated: | January 10, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency (PMDA) |
ClinicalTrials.gov processed this record on May 22, 2013