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A single center, prospective, randomized, controlled trial: the safety and efficacy of pregabalin combined with gastric motility drugs in the treatment of belch patients

A single center, prospective, randomized, controlled trial: the safety and efficacy of pregabalin combined with gastric motility drugs in the treatment of belch patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028120
Enrollment
Unknown
Registered
2019-12-12
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

Belching

Interventions

Group A:Mosapride tablets (5mg, 3 times / d)
Group B:Mosapride tablets (5mg, 3 times / d), combined with pregabalin (75mg, 3 times / d)
Group C:Pregabalin (75mg, 3 times /d)

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) male or female aged >=17 years old; (2) according to the diagnostic criteria of Roman IV for belching: symptoms should be present for at least 6 months, and the following diagnostic criteria should be met in the past 3 months. It includes excessive upper gastric belching and excessive upper gastric belching; frequent and repeated belching is observed to support upper gastric belching; there is no clear clinical relationship between upper gastric belching; if necessary, intracavitary impedance detection is needed to distinguish upper gastric belching and upper gastric belching; symptoms appear at least 6 months before diagnosis, and meet the above diagnostic criteria in the past 3 months; (3) patients with belching as the first complaint and main symptoms; (4) the subjects understood the whole clinical research process and were able to cooperate with the whole follow-up and efficacy evaluation. (5) It is agreed to take effective contraceptive measures within 3 months from the signing of informed consent to the end of the last trial medication.

Exclusion criteria

Exclusion criteria: 1. Used or allergic to pregabalin within 30 days; 2. Those with gastrointestinal or abdominal operation history within 3 months before screening; 3. Gastroscopic examination found that the gastrointestinal ulcer, tumor, inflammation and other organic lesions; 3. Alcohol addicts; 4. With serious cardiovascular system, liver, respiratory system, urinary system, nervous system, mental system, systemic diseases and immune deficiency diseases, which are not suitable for the researchers; 5. Abnormal laboratory examination which with clinical significance, and the researcher judges that it is not suitable to participate in the study; 6. Planned pregnancy or pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Belching score;

Countries

China

Contacts

Public ContactWei Han

Qilu Hospital of Shandong University

hanwei@sdu.edu.cn+86 18560086098

Outcome results

None listed

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