Efficacy and safety of Clidinium bromide and Chlordiazepoxide hydrochloride combination as add-on therapy in functional dyspepsia

Phase 3

Recruiting

• Conditions: Functional dyspepsia; Clidinium bromide; Chlordiazepoxide hydrochloride

• Registration Number: TCTR20171016004
• Lead Sponsor: The Gastroenterological Association of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-16
• Study Completion: 2018-03-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Patients age 18-70 years
Diagnosed functional dyspepsia according to Rome IV criteria
Normal upper endoscopy within 1 year
No evidence of Helicobacter pylori infection
Partial or non-rensponder to proton pump inhibitor standard treatment

Exclusion Criteria

History of irritable bowel syndrome
Major physical illness
Current active alcohol abuse
History of obstructive uropathy
Pregnancy and Lactation
History of allergy to benzodiazepine, proton pump inhibitor, antispasmodic and anticholinergic drug.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global overall symptom scale Day 0 (at baseline), End of week 1, End of week 2, End of week 3 , End of week 4 score

Secondary Outcome Measures

Name	Time	Method
Short form Nepean dyspepsia index Day 0 (at baseline), End of week 4 score