A Study to Track the Safety of Vesomni in Men in South Korea Treated in Routine Clinical Practice for the Urinary Symptoms of Benign Prostatic Hyperplasia (Enlarged Prostate)
Post-marketing Observational Study for Vesomni Modified Release Tablet 6 mg/0.4 mg (Solifenacin Succinate/Tamsulosin Hydrochloride) in Male Patients With Moderate to Severe Storage Symptoms and Voiding Symptoms Associated With BPH Who Are Not Adequately Responding to Treatment With Tamsulosin Monotherapy in South Korea
Benign prostatic hyperplasia (BPH), also known as an enlarged prostate, happens more often in men as they age. This condition causes a sudden need to pass urine, which is hard to control. Men with an enlarged prostate may need to pass urine many times during the day and night which can affect their wellbeing. There are treatments available, like tamsulosin but they don't work well in some men and can cause further health problems. Vesomni is approved in South Korea to treat urinary symptoms in men with an enlarged prostate, when treatment with tamsulosin doesn't work well enough.
This study will track the safety of Vesomni given to men in South Korea who have moderate to severe symptoms from an enlarged prostate, who have previously been treated with tamsulosin and found it didn't work well. The safety of Vesomni is tracked by mainly collecting information from their medical records. The sponsor will ask for extra information to be collected, and if any health problems were caused by Vesomni. In this study, researchers want to learn about the safety of Vesomni and how well it controls symptoms in men with an enlarged prostate.
The men's own doctor decides on treatment, as part of routine clinical practice, not the sponsor (Astellas). This study is about collecting information only. Most information about the safety and control of symptoms will be collected from medical records. The sponsor will also ask for extra information to be collected. All information will be collected for up to 24 weeks after the men start treatment with Vesomni.
調査の概要
詳細な説明
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Astellas Pharma Korea, Inc
- 電話番号：800-888-7704
- メール：Astellas.registration@astellas.com
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- A patient (adult male) who receives treatment with Vesomni, according to the approved local label during the registration period.
Exclusion Criteria:
- A patient with any contraindication for Vesomni, according to the approved local label.
- A patient who enrolled or is planning to enroll in any study of an investigational medicine during the observation period.
研究計画
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 |
|---|---|
|
Vesomni
Participants who are not adequately responding to treatment with tamsulosin monotherapy who receive Vesomni modified release tablet 6 mg/0.4 mg in routine clinical practice according to the drug label approved at the time of marketing authorization.
|
Oral administration
他の名前：
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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 Adverse Events (AEs) or Adverse Drug Reactions (ADR)
時間枠：Up to 24 Weeks
|
An AE is defined as any untoward medical occurrence in a participant administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product whether or not considered related to the medicinal (investigational) product. An ADR is defined as any noxious and unintended response associated with the use of a drug in humans, at any dose, where a causal relationship is at least a reasonable possibility. |
Up to 24 Weeks
|
|
Number of Participants With Serious AE (SAE)/ Serious ADR (SADR)
時間枠：Up to 24 Weeks
|
An AE is considered "serious" if it results in death or life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a medically important event or reaction
|
Up to 24 Weeks
|
|
Number of Participants With an Unexpected AE (UAE)/ Unexpected ADR (UADR)
時間枠：Up to 24 Weeks
|
An UAE is an AE that the nature or severity of which is not consistent with the information described in the approved Korean product label
|
Up to 24 Weeks
|
|
Number of Participants With Important Risks
時間枠：Up to 24 Weeks
|
An important risk is classified as either an important identified risk and/or an important potential risk. An "Important Identified Risk" refers to an undesirable clinical outcome, with sufficient scientific evidence through clinical trials or post-marketing data to confirm that the undesirable clinical outcome is caused by the drug, and which have the potential to affect the risk-benefit balance of a product. An "Important Potential Risk" refers to an undesirable clinical outcome, with some, but not sufficient, evidence to confirm that the undesirable clinical outcome is caused by the drug. These risks may have the potential to affect the risk-benefit balance of a product, and therefore require ongoing monitoring and assessment. |
Up to 24 Weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes From Baseline in Total Score of the International Prostate Symptom Score (IPSS)
時間枠：Baseline, Week 12 and 24
|
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL.
Each of the 7 symptom questions is scored from 0 to 5, indicating increasing severity of the symptom, with a total score ranging from 0 to 35.
|
Baseline, Week 12 and 24
|
|
Change From Baseline in Storage Subscore of IPSS
時間枠：Baseline, Week 12 and 24
|
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL.
The storage sub-score of the IPSS, which is calculated from the frequency, urgency, and nocturia sections of the IPSS total score, is used to evaluate the degree of urinary storage symptoms related to BPH.
Each question in the storage sub-score is scored from 0 to 5, indicating increasing severity of the symptom, with a total score range from 0 to 15.
|
Baseline, Week 12 and 24
|
|
Change From Baseline in Quality of Life (QoL) Score of IPSS
時間枠：Baseline, Week 12 and 24
|
The IPSS is used to evaluate the degree of "bother" from urinary symptoms, based on answers to 7 questions concerning urinary symptoms related to BPH, and 1 additional question assessing the impact of these symptoms on the patient's QoL.
The QoL question is scored separately on a scale from 0 (delighted) to 6 (terrible), reflecting the patient's subjective satisfaction with their urinary condition.
|
Baseline, Week 12 and 24
|
協力者と研究者
捜査官
- スタディディレクター：Central Contact、Astellas Pharma Korea, Inc.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- EC905-PV-0001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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