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New treatment option for Functional Dyspepsia
Official title Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
ClinicalTrials.gov ID: NCT07008235
What this study is testing
What is Tablet Amitriptyline 10 milligrams?
Tablet Amitriptyline 10 milligrams is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for functional dyspepsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Age 18 years or more
- Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria
- Patients who are willing to sign informed written consent
You likely can't join if
- Structural lesion in Upper GI endoscopy and/or positive CLO test
- Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms
- History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major...
- Previous history of gastrointestinal surgery
- Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated...
- Any patient with ongoing treatment with antidepressants or antipsychotics
See the full eligibility criteria
- Age 18 years or more
- Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria
- Patients who are willing to sign informed written consent
- Structural lesion in Upper GI endoscopy and/or positive CLO test
- Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms
- History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders
- Previous history of gastrointestinal surgery
- Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine
- Any patient with ongoing treatment with antidepressants or antipsychotics
- Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine
- Patients for whom Amitriptyline and Trifluoperazine are contraindicated
- Elderly patients\> 60 years
- Pregnancy and breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Dhaka, Bangladesh
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dhaka, Bangladesh. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.