gastroesophageal reflux disease. Gastro- oesophageal reflux disease
Conditions
Interventions
Intervention 1: Midodrine, tablet 5 mg, 3 timesper day for one month. Intervention 2: Midodrine, tablet 2.5mg, 3 times per day for one month. Intervention 3: Placebo, tablet, 3 times per day for one m
Treatment - Drugs
Placebo
Midodrine, tablet 5 mg, 3 timesper day for one month
Midodrine, tablet 2.5mg, 3 times per day for one month
Placebo, tablet, 3 times per day for one month
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: age more than 18 and below 65; presence of at least one symptom compatible compatible with GERD including epigastric or retrosternal burning sensation, regurgitation, or acid taste in the mouth; lack of response to the proper consumption of pantoprazole 40 mg twice daily for a minimum of one month. Exclusion criteria: dominant symptom of dysphagia; history of surgery of the upper GI system; concomitant GI diseases such as NET, malignancy, peptic ulcer disease; presence of other diseases like hypertension, cardiovascular diseases, history of urinary retention, hypersensitivity to midodrine, leg cramp or vascular insufficiency in the abdomen or legs, acute or chronic renal dysfunction with GFR < 50%, thyroid disease, diabetes mellitus, pheochromocytoma, liver cirrhosis, asthma or COPD; use of medications affecting lower esophageal sphincter such as theophylline, beta blockers, NSAIDs, steroids, bronchodilators; antihistamine taking; pregnancy and lactation; psychiatric disorders or use of antidepressive agents; current smoker; alcohol consumption; use of narcotics or illicit drugs; history of glaucoma.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity. Timepoint: Weekly. Method of measurement: Visual scale 0-10.;Quality of life. Timepoint: Every 2 weeks. Method of measurement: GERD quality of life standardized qustionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Lower esophageal sphincter pessure. Timepoint: One month. Method of measurement: Mannometry.;Esophageal residual acid reflux. Timepoint: Monthly. Method of measurement: pH meter. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholam Reza Sivandzadeh
Gastroenterohepatology research center
Outcome results
None listed