胃食道逆流症患者におけるフェクスプラザンとエソメプラゾールの比較試験

実験的：フェクスプラザン 40 mg

このアームに割り当てられた参加者は、カリウム競合的酸ブロッカー（P-CAB）であるフェクスプラザン40mgを1日1回経口投与で受けました。 初期治療期間は4週間でした。 初期治療期間後に十分な症状緩和が得られなかった参加者は、フェクスプラザン40mgによる治療をさらに4週間継続し、最大治療期間は8週間でした。 治療遵守状況と安全性は、研究期間中、プロトコルに従って監視されました。

薬：フェクスプラザン

フェキスプラザンは、1日1回40 mgの用量で経口投与されました。 参加者は、最初の4週間の期間で治療を受けました。 初期治療期間後に十分な症状緩和が得られなかった参加者は、フェキスプラザンによる治療をさらに4週間継続し、最大8週間の治療期間となりました。

他の名前：

• フェクスルー
• DWP14012

アクティブコンパレータ：エソメプラゾール 40 mg

このアームに割り当てられた参加者は、プロトンポンプ阻害薬であるエソメプラゾール40mgを1日1回経口投与で受けました。 初期治療期間は4週間でした。 初期治療期間後に十分な症状緩和が得られなかった参加者は、エソメプラゾール40mgによる治療をさらに4週間継続し、最大治療期間は8週間でした。 治療遵守状況と安全性は、試験期間中、プロトコルに従って監視されました。

薬：エソメプラゾール

エソメプラゾールは、40 mgを1日1回経口投与されました。 参加者は最初の4週間の治療を受けました。 初期治療期間後に十分な症状緩和が得られなかった参加者は、エソメプラゾールによる治療をさらに4週間継続し、最大治療期間は8週間でした。

他の名前：

• ネキシウム

Proportion of Participants With Symptom Relief at Week 4 (GERD-Q Score <8)

Symptom relief was assessed using the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater severity and higher likelihood of GERD). The primary outcome was defined as the proportion of participants with a GERD-Q total score <8 at Week 4, indicating adequate relief of GERD symptoms.

Proportion of Participants With Symptom Relief at Week 8 (GERD-Q Score <8)

The proportion of participants who achieved symptom relief at Week 8, defined as a total score of less than 8 on the Gastroesophageal Reflux Disease Questionnaire (GERD-Q). The GERD-Q total score ranges from a minimum of 0 to a maximum of 18, where higher scores indicate a worse outcome (greater symptom severity). This assessment applied only to participants who continued treatment beyond the initial 4-week period.

Time to Complete Symptom Response After First Dose

Complete response was defined as the absence of heartburn and/or acid regurgitation symptoms for 7 consecutive days based on patient diaries. Time to complete response was measured in days from the first dose to the first day of the 7-day symptom-free period. Analysis included all subjects using time-to-event methods.

Number of Participants Without Major GERD Symptoms

The number of participants without major GERD symptoms (heartburn and/or acid regurgitation) during predefined periods, including the first 7 days, 4 weeks, and 8 weeks after initiation of treatment, as recorded in participant diaries.

Percentage of Days Free of Major GERD Symptoms

The percentage of days without heartburn and/or acid regurgitation per participant during the first 7 days, 4 weeks, and 8 weeks after treatment initiation. This includes daytime, nighttime, and combined daytime/nighttime periods based on participant diary entries, analyzed and reported as the mean percentage of symptom-free days

Change From Baseline in GERD-Q Total Score

Change from baseline in the Gastroesophageal Reflux Disease Questionnaire (GERD-Q) total score. The GERD-Q is a 6-item scale used to evaluate the frequency of GERD symptoms. Total scores range from a minimum of 0 to a maximum of 18, where higher scores indicate greater symptom severity (a worse outcome).

Change From Baseline in GERD-Health-Related Quality of Life (GERD-HRQL) Total Score

Change from baseline in the Gastroesophageal Reflux Disease-Health-Related Quality of Life (GERD-HRQL) total score. The GERD-HRQL is a 10-item instrument used to assess the impact of symptoms on daily life. Total scores range from a minimum of 0 to a maximum of 50, where higher scores indicate worse health-related quality of life (a worse outcome).

Number of Participants With Relief From Chronic Cough

The number of participants who experienced relief from chronic cough symptoms during predefined periods after initiation of study treatment, based on participant diary assessments.

Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom of chronic cough at baseline, while all post-baseline time points report the number of participants that experienced symptom relief.

Number of Participants With Relief of Throat Irritation Sensation

The number of participants who experienced relief of throat irritation or foreign body sensation during predefined periods after initiation of study treatment, as recorded in participant diaries.

Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom at baseline, while all post-baseline time points report the number of participants that experienced symptom relief.

Number of Participants Without Nocturnal GERD Symptoms

The number of participants who were not awakened from sleep due to heartburn or acid regurgitation during predefined periods after initiation of study treatment, as recorded in participant diaries.

Note: The "Baseline" rows report the number of participants who indicated they experienced the symptom at baseline, while all post-baseline time points report the number of participants that experienced symptom relief.