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A single-center, prospective, randomized, controlled clinical trial: a clinical study for the safety and efficacy of pregabalin in the treatment of central - mediated abdominal pain syndrome

A single-center, prospective, randomized, controlled clinical trial: a clinical study for the safety and efficacy of pregabalin in the treatment of central - mediated abdominal pain syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028026
Enrollment
Unknown
Registered
2019-12-08
Start date
2020-01-01
Completion date
Unknown
Last updated
2019-12-10

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

Conditions

Centrally mediated abdominal pain syndrome

Interventions

Group A:Pinaverium bromide 50mg p.o. t.i.d.
Group B:Pinaverium bromide 50mg p.o. t.i.d. and Pregabalin 75mg p.o. t.i.d.
Group C:Pregabalin 75mg p.o. t.i.d.

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 70 years old (male or female). 2. In accordance with the Roman ? functional gastrointestinal disease diagnostic criteria: about CAPS symptoms should be at least 6 months, and meet the following criteria for the diagnosis of nearly three months. Persistent or nearly persistent abdominal pain; Has nothing to do with physical behavior (eating, defecating, menstruation, etc.) or only occasionally; Abdominal pain caused by daily work, life restrictions; Pain is not a disguise; Abdominal pain cannot be explained by other organic, functional gastroenteropathy or other diseases. 3. Subjects understand the whole clinical study process, and have the ability to cooperate with the completion of the whole follow-up and efficacy evaluation.

Exclusion criteria

Exclusion criteria: 1. Have used pregabalin within 30 days or are allergic to pregabalin; 2. The use of narcotic drugs, non-narcotic analgesics, gastrointestinal antispasmodic drugs, proton pump inhibitors, sleeping pills; 3. Gastrointestinal ulcer, tumor, inflammation and other organic lesions found by gastroenteroscopy; 4. Have a history of mental illness or cognitive impairment; 5. Alcohol dependence; 6. Have serious heart, lung, liver, kidney and other chronic diseases; 7. Planned pregnancy or gestation, breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Abdominal pain 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 10, 2026