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IRCT201402274226N2 IRCT 2014-04-04 Shiraz University of Medical Sciences Midodrine and refractory gastroesophageal disease The therapeutic effect of Midodrine in patients with refractory gastro esophageal reflux disease: a randomized double-blind clinical trial 2014-04-21 anticipated 60 Complete https://irct.ir/trial/4486 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 0 (exploratory trials) gastroesophageal reflux disease. 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 month.
public Gholam Reza Sivandzadeh
Gastroenterohepatology research center - Namazi hospital
Shiraz Iran (Islamic Republic of) 71935-1311 +98 71 1647 3236 ghsivand@sums.ac.ir ; grc@sums.ac.ir Gastroenterohepatology research center scientific Kamran Bagheri Lankarani
Health policy research center- Shiraz medical school
Shiraz Iran (Islamic Republic of) +98 71 1230 1596 lankaran@sums.ac.ir; lankarani@mohme.gov.ir Gastroenterohepatology research center, Shiraz University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 65 years Both K21 Gastro- oesophageal reflux disease Treatment - Drugs 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 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. Lower esophageal sphincter pessure. Timepoint: One month. Method of measurement: Mannometry. Esophageal residual acid reflux. Timepoint: Monthly. Method of measurement: pH meter. Shiraz University of Medical Sciences Approved 2014-02-24 Shiraz Uiversity of Medical Scienes Namazi square, Zand street Shiraz Iran (Islamic Republic of)