functional heartburn
Conditions
Interventions
Amitriptylin 25-50 mg daily or placebo for 6 weeks in a crossover design.
Sponsors
AMC Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Minimum age: 18 years; 2. Documented functional heartburn: A. Negative esophagogastroduodenoscopy and no history of reflux esophagitis; B. Negative 24h pH/impedance recording (physiological acid exposure time) and negative symptom association probability.
Exclusion criteria
Exclusion criteria: 1. Surgery of the esophagus; 2. Motility disorders of the GI tract leading to delayed gastric emptying or altered intestinal motility; 3. 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; 4. Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders); 5. 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; 6. Medication-related: A. Contra-indications for amitriptyline use: epilepsy, organic central nervous system disorders, prostate hypertrophy, pyloric stenosis, cardiovascular disease, hyperthyroidism, liver- and kidney function impairment; B. Interaction can occur with barbiturates, carbamazepine, ketoconazol and ritonavir . Concommitant use of MAO-inhibitors is contra-indicated. 7. Hypersensitivity to the active substance or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Esophageal sensitivy to acid perfusion (perfusion-related symptom score). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to symptoms during esophageal acid exposure; 2. Symptom severity during esophageal acid exposure (visual analog scale or VAS); 3. GERD symptom score improvement after an 8 week treatment with amitriptyline (GERDQ questionnaire, RDQ questionnaire, SF-LDG questionnaire); 4. Quality of life assessment (GERD-QoL questionnaire); 5. Psychological state and anxiety assessment (HADS and SF12 questionnaire). | — |
Contacts
Public ContactA.J. Bredenoord
Meibergdreef 9
Outcome results
None listed