Long Term Use of Somatropin in Patients Small for Gestational Age
2013年12月17日 更新者:Pfizer
Special Investigation Of Long Term Use Of Genotropin For SGA (Regulatory Post Marketing Commitment Plan)
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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
920
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
確率サンプル
調査対象母集団
The patients whom an investigator involving A6281292 prescribes the Somatropin (Genotropin® ).
説明
Inclusion Criteria:
- Patients need to be administered Somatropin (Genotropin®) in order to be enrolled in the surveillance.
Exclusion Criteria:
- Patients not administered Somatropin (Genotropin®).
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
ソマトロピン
ソマトロピンを投与された患者。
|
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."
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Participants With Treatment Related Adverse Events.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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
時間枠: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.
時間枠: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.
時間枠: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).
時間枠: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.
時間枠: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.
時間枠: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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年2月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2012年12月1日
試験登録日
最初に提出
2008年11月17日
QC基準を満たした最初の提出物
2008年11月17日
最初の投稿 (見積もり)
2008年11月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2014年2月6日
QC基準を満たした最後の更新が送信されました
2013年12月17日
最終確認日
2013年12月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- A6281292
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