Efficacy of nocturnal symptoms and esophageal acid exposure in GERD patients: a randomized controlled study of PPI combined with lafutidine versus PPI alone

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200055479

Enrollment

Unknown

Registered

2022-01-10

Start date

2022-01-20

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastroesophageal reflux disease

Interventions

Experimental group:PPI combined with lafutidine

Control group:PPI

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18-65 years; 2. Gender is not limited; 3. GERD-Q reaches 8 points and nocturnal symptoms; 4. Completed upper gastrointestinal endoscopy, willing to take the study drug and willing to accept esophageal manometry and pH monitoring.

Exclusion criteria

Exclusion criteria: 1. There are contraindications to esophageal manometry and pH monitoring, such as cardiopulmonary dysfunction, esophageal stenosis or varicose veins, etc.; 2. Pregnant patients and lactating patients; 3. Participating in other clinical studies; 4. Communication and cooperation ability barriers.

Design outcomes

Primary

Measure	Time frame
24h esophageal acid exposure time;acid breakout at night;	—

Secondary

Measure	Time frame
nocturnal symptom relief;	—

Countries

China

Contacts

Public ContactHou Xiaohua

houxh@hust.edu.cn+86 27 85726057

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026