Tailored treatment of functional dyspepsia with nortriptyline: a multi-center double-blind placebo-controlled trial (TENDER)

Phase 3

Recruiting

Conditions: Functional Dyspepsia / indigestion
10018012

Registration Number: NL-OMON52924

Lead Sponsor: niversiteit Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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.

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 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Response to therapy, as defined by a 30% reduction from baseline (i.e. the<br /><br>run-in period) in the weekly average of daily symptom scores, during at least<br /><br>50% of weeks 3-12 of treatment. This is in line with the FDA guidelines on IBS<br /><br>treatment studies. Recorded symptoms include the five core symptoms of FD:<br /><br>epigastric pain, epigastric burning, postprandial fullness, early satiety and<br /><br>upper abdominal bloating.<br /><br><br /><br>Self-reported weekly global adequate relief of symptoms (defined as a yes in<br /><br>at least 50% of weeks 3-12 of the treatment), collected<br /><br>electronically. Weeks 1 and 2 are excluded in order to allow for establishment<br /><br>of steady-state drug levels</p><br>

Secondary Outcome Measures