Personalized treatment of functional dyspepsia with nortriptyline

Phase 1

• Conditions: Functional dyspepsia (FD); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-003307-21-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

- Patients with functional dyspepsia (FD), diagnosed according to the Rome IV criteria
- Age 18-65 years
- Predicted CYP2D6 extensive metabolizer phenotype on the basis of CYP genotyping
- In the presence of alarm symptoms, patients are required to have undergone a upper gastrointestinal endoscopy (without evidence of organic disease), and have tested negative for Helicobacter pylori 2 years prior to inclusion.
- Insufficient effect of first line treatment with proton pump inhibitors or prokinetics.
- Women in their fertile age (<55 years old) must use contraception or be postmenopausal for at least two years.

Patients are recruited in primary and secondary/tertiary healthcare settings.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History of gastric ulcer;
-Evidence of current anxiety and/or depression disorder as defined by a score = 10 on the GAD-7 and/or PHQ-9 questionnaire, supported by a detailed interview by the investigator (i.e. the investigator is required to confirm suspicion of anxiety or depressive disorder);
-Predicted CYP2D6 poor, intermediate or ultrarapid metabolizer phenotype on the basis of CYP genotyping
-Current use or any previous use of psychotropic medication in the last 3 months prior to inclusion;
-Inability to discontinue prokinetics*, NSAIDs or opioids;
- Excessive alcohol consumption, defined as > 2 of 3 units per day (females and males respectively)
-Using drugs of abuse;
- Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
a.Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
b. Other surgery upon judgment of the principle investigator;
-History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
-Pregnancy or lactation.
- History of epilepsy
- History of glaucoma

* Patients still using prokinetics at the time of inclusion will be asked to discontinue treatment. A wash-out period of 2 weeks before the run-in period is required. Patients that cannot discontinue prokinetic therapy will be excluded. Patients on proton pump inhibitors should continue these without altering dosage, given that rebound symptoms can occur with discontinuation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified