ow-dose amitriptyline in uninvestigated dyspepsia: a pragmatic open-label cluster randomized controlled trial

Phase 2

Recruiting

• Conditions: Dyspepsia is a gastrointestinal disorder that is found in up to 20 percent of the world' s population. Symptoms are often chronic, resulting in a poor quality of life. The most common cause is function; Uninvestigated dyspepsia, Low dose amitriptyline, indigestion

• Registration Number: TCTR20201218006
• Lead Sponsor: antikarn Yingrattanasuk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-18
• Study Completion: 2021-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients with functional dyspepsia as defined by Rome IV criteria who have not had an endoscopy (uninvestigated dyspepsia).

2. No history of taking the following drugs for at least 1 week: proton pump inhibitor, antacid, H2antagonist, prokinetic, antispasmodic, carminative.

Exclusion Criteria

1. Have a history of hypersensitivity to Amitriptyline and / PPIs, or have a history of pregnancy or breastfeeding.
2. Have gastric malignancy, cardiac arrhythmia, congestive heart failure, untreated glaucoma, benign prostate hypertrophy, uncontrolled diabetes.
3. Have a history of using drug groups Antidepressant, Benzodiazepine, NSAIDs including fluoxetine, citalopram, fluvoxamine, sertraline, escitalopram, paroxetine, nortriptyline, mirtazapine, trazodon, chlordiazepoxide, clonazepam, clorazepate, clobazam, diazepam, flurazepam, lorazepam, midazolam, prazepam,triazolam, ibuprofen, naproxen, diclofenac, mefenamic acid, indomethacin and aspirin.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global overall symptom scale of dyspepsia 8 weeks self assessment

Secondary Outcome Measures

Name	Time	Method
Global overall symptom scale of dyspepsia 8 weeks self assessment report