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A randomized, double-blind, placebo-controlled clinical study of gabapentin for rapid symptom relief in patients with gastroesophageal reflux-induced chronic cough

A randomized, double-blind, placebo-controlled clinical study of gabapentin for rapid symptom relief in patients with gastroesophageal reflux-induced chronic cough

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058071
Enrollment
Unknown
Registered
2022-03-28
Start date
2022-10-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

gastroesophageal reflux-induced chronic cough (GERC)

Interventions

Experimental group:Giving gabapentin
Control group:Giving placebo

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years; 2. Cough duration >8 weeks, chest imaging is normal, with or without reflux symptoms such as acid reflux, heartburn and retrosternal pain; 3. MII-pH monitoring showed AET>6% and/or SAP>= 95%; 4. Upper airway cough syndrome, cough variant asthma, and eosinophilic bronchitis were not diagnosed based on medical history and laboratory examination, or the cough was not relieved or only partially relieved by treatment for these causes; 5. No contraindications for gabapentin therapy.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating patients or those who refuse to sign the informed consent; 2. Smoking or quitting for less than 2 years; 3. Patients who have used proton pump inhibitors, gastric motogens or gabapentin within 2 months; 4. Medical history of respiratory tract infection within 8 weeks; 5. The researcher believes that there are other conditions that are not suitable for entering the study.

Design outcomes

Primary

MeasureTime frame
Leicester Quality of Life Questionnaire Score;Cough Symptom Score;Gastroesophageal Reflux Disease Questionnaire (GerdQ);Hull Airway Reflux Questionnaire;Capsaicin cough sensitivity;

Secondary

MeasureTime frame
Substance P in induced sputum;Induction of calcitonin gene peptide in sputum;Multi-channel intraluminal impedance combined with pH monitoring;

Countries

China

Contacts

Public ContactXu Xianghuai

Shanghai Tongji Hospital

05849@tongji.edu.cn+86 13764459488

Outcome results

None listed

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