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Clinical efficacy and safety of prokinetic agents as maintenance therapy for functional dyspepsia (FD): a real world study

Clinical efficacy and safety of prokinetic agents as maintenance therapy for functional dyspepsia (FD): a real world study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042166
Enrollment
Unknown
Registered
2021-01-14
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

functional dyspepsia

Interventions

maintenance therapy / on-demand therapy / drug withdrawal group:Not applicable

Sponsors

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Rome IV diagnostic criteria for functional dyspepsia are adopted. 2. Patients with one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning (with or without epigastric bloating, belching, and nausea), and without evidence of organic, systemic or metabolic diseases found in routine examination and endoscopic examination which could explain the symptoms, will be included in this study. 3. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis. 4. If the above symptoms are relieved by evacuation of feces or gas, they should generally not be considered as functional dyspepsia. Patients are eligible for this study whether they have previously used prokinetic drugs (such as, domperidone, mosapride, itopride, and sinipride, etc.) or not.

Exclusion criteria

Exclusion criteria: 1. Patients with mental and language disorders; 2. Patients who are allergic to prokinetic drugs or their components; 3. Patients who have gastrointestinal alarm symptoms: unexplained weight loss, repeated vomiting, progressive dysphagia, hematemesis, melena, etc.; 4. Helicobacter pylori associated dyspepsia (positive results for Helicobacter pylori test, or less than 12 months after Helicobacter pylori eradication; dyspepsia caused by NSAIDs or other drugs; 5. Other serious organic, systemic or metabolic diseases; 6. Other situations that may add difficulties to enrollment or follow-up, such as frequent changes in the working places.

Design outcomes

Primary

MeasureTime frame
Overall effective rate;

Secondary

MeasureTime frame
Effective rate of single symptom;Overall symptom score;Single symptom score;Treatment response rate;Symptom relief rate;

Countries

China

Contacts

Public ContactXiaohua Hou

Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn+86 15802734363

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 17, 2026