위식도 역류질환 환자를 대상으로 펙수프라잔과 에소메프라졸을 비교하는 연구

실험적: Fexuprazan 40 mg

이 군에 배정된 참가자들은 칼륨 경쟁적 산분비 억제제(P-CAB)인 펙수프라잔 40mg을 1일 1회 경구 투여 받았습니다. 초기 치료 기간은 4주였습니다. 초기 치료 기간 이후 충분한 증상 완화를 달성하지 못한 참가자들은 펙수프라잔 40mg으로 추가 4주간 치료를 계속하여 최대 8주간 치료를 받았습니다. 치료 순응도와 안전성은 연구 기간 동안 프로토콜에 따라 모니터링되었습니다.

의약품: 펙수프라잔

펙수프라잔은 1일 1회 40mg 용량으로 경구 투여되었습니다. 참가자들은 초기 4주 동안 치료를 받았습니다. 초기 치료 기간 후 충분한 증상 완화를 달성하지 못한 참가자들은 추가 4주 동안 펙수프라잔 치료를 지속하여 최대 8주까지 치료를 받았습니다.

다른 이름들:

• Fexuclue
• DWP14012

활성 비교기: 에소메프라졸 40 mg

이 군에 배정된 참가자들은 양성자 펌프 억제제인 에소메프라졸 40mg을 하루에 한 번 경구 투여 받았습니다. 초기 치료 기간은 4주였습니다. 초기 치료 기간 후 충분한 증상 완화를 달성하지 못한 참가자들은 추가로 4주 동안 에소메프라졸 40mg으로 치료를 계속하여 최대 8주까지 치료를 받았습니다. 치료 순응도와 안전성은 연구 기간 동안 프로토콜에 따라 모니터링되었습니다.

의약품: 에소메프라졸

에소메프라졸은 40mg의 용량으로 하루에 한 번 경구 투여되었습니다. 참가자들은 초기 4주 동안 치료를 받았습니다. 초기 치료 기간 후 적절한 증상 완화를 달성하지 못한 참가자들은 추가로 4주 동안 에소메프라졸 치료를 계속하여 최대 8주 동안 치료를 받았습니다.

다른 이름들:

• 넥시움

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.