functional heartburn pyrosis
Conditions
Interventions
treatment with placebo or amitriptyline 25-50 mg daily for 6 weeks in a
crossover design, with an 8 week washout period in between
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Minimum age: 18 years * Documented functional heartburn * Negative esophagogastroduodenoscopy and no history of reflux esophagitis * Negative 24h pH/impedance recording (physiological acid exposure time) and negative symptom association probability
Exclusion criteria
Exclusion criteria: * Surgery of the esophagus * Motility disorders of the GI tract leading to delayed gastric emptying or altered intestinal motility * Use of any medication with a potential effect on upper gastrointestinal motility and/or sensitivity that can not be stopped for the duration of the study. If this medication can be stopped, it should be discontinued for at least 2 weeks before the start of the study. * Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) * Pregnancy or lactation. A pregnancy test will be carried out prior to inclusion in the study. Female patients who are premenopausal and have a negative pregnancy test should be on an anticonceptive.;* Medication-related * Contra-indications for amitriptyline use: epilepsy, organic central nervous system disorders, prostate hypertrophy, pyloric stenosis, cardiovascular disease, hyperthyroidism, liver- and kidney function impairment. * Interaction can occur with barbiturates, carbamazepine, ketoconazol and ritonavir . Concommitant use of MAO-inhibitors is contra-indicated. * Hypersensitivity to the active substance or to any of the excipients.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Esophageal sensitivy to acid perfusion (perfusion-related symptom score). Time to symptoms during esophageal acid exposure and balloon distension Symptom severity during esophageal acid exposure and balloon distension (visual analog scale or VAS) Psychological state and anxiety assessment (HADS and SF12 questionnaire) | — |
Primary
| Measure | Time frame |
|---|---|
| GERD symptom score improvement after an 8 week treatment with amitriptyline (GERDQ questionnaire, RDQ questionnaire) | — |
Countries
Netherlands
Outcome results
None listed