Midodrine and refractory gastroesophageal disease

Early Phase 1

• Conditions: gastroesophageal reflux disease.; Gastro- oesophageal reflux disease

• Registration Number: IRCT201402274226N2
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
ower esophageal sphincter pessure. Timepoint: One month. Method of measurement: Mannometry.;Esophageal residual acid reflux. Timepoint: Monthly. Method of measurement: pH meter.