一项比较非苏拉赞和埃索美拉唑在胃食管反流病患者中的研究

实验性的：非苏拉赞 40 毫克

该组参与者接受口服钾竞争性酸阻滞剂（P-CAB）非苏拉赞40 mg，每日一次给药。初始治疗期为4周。初始治疗后症状缓解不充分的参与者继续接受非苏拉赞40 mg治疗额外4周，最长治疗持续时间为8周。根据研究方案，在整个研究期间监测治疗依从性和安全性。

药品：菲索普拉赞

Fexuprazan以每日一次、每次40 mg的剂量口服给药。 参与者接受为期4周的初始治疗。 在初始治疗期后未获得充分症状缓解的参与者继续接受fexuprazan治疗额外4周，最长治疗持续时间为8周。

其他名称：

• 费克鲁
• DWP14012

有源比较器：埃索美拉唑 40 毫克

被分配至该组的参与者接受了埃索美拉唑40毫克（一种质子泵抑制剂）的治疗，每日口服一次。初始治疗期为4周。在初始治疗期后未获得充分症状缓解的参与者继续接受埃索美拉唑40毫克治疗额外4周，最长治疗持续时间为8周。在整个研究期间，根据方案对治疗依从性和安全性进行了监测。

药品：埃索美拉唑

埃索美拉唑以每日一次40毫克的口服剂量给药。 参与者在初始阶段接受为期4周的治疗。 在初始治疗期后未获得足够症状缓解的参与者继续接受埃索美拉唑治疗额外4周，最长治疗持续时间为8周。

其他名称：

• 耐讯

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.