Protocol summary

Summary
Gastro-oesophageal reflux disease (GERD) is known as esophageal mucosal injury or regurgitation of stomach contents. Acid reducing agents, particularly proton pump inhibitors (PPI), are effective in the management of GERD. However, about 20-30 % of affected cases do not respond to these agents. Therefore, other drugs that could affect the lower esophageal sphincter pressure or diminish its transient relaxations are possible choices. It is presumed that midodrine, an alpha agonist drug, may be effective in treating refractory patients according to above mentioned mechanisms. In this clinical trial, midodrine would be compared with placebo. Sixty patients between 18 to 65 ages who have already experienced at least one of the symptoms of heartburn or regurgitation despite one month consumption of High-dose PPIs will be included. Those with history of gastrointestinal surgery, concomitant diseases, use of certain medications, dysphagia and pregnancy are excluded from the study. Upper endoscopy with biopsy will be performed first. Then, randomly, cases are placed into 3 groups, one as placebo and two others taking two different dosages of midodrine for one month. As the primary outcome, patients are asked to score the intensity of their symptoms, based on a 0-10 visual scale, at the beginning of the study and then weekly up to 2 weeks after drug cessation. Previously validated Gastro esophageal reflux quality of life questionnaire will be filled out by the attendant manager biweekly. Finally, statistical analysis will be conducted.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201402274226N2
Registration date: 2014-04-04, 1393/01/15
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-04-04, 1393/01/15
Registrant information
Name
Gholam Reza Sivandzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4316
Email address
ghsivand@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The therapeutic effect of Midodrine in patients with refractory gastro esophageal reflux disease: a randomized double-blind clinical trial
Public title
Midodrine and refractory gastroesophageal disease
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz Uiversity of Medical Scienes
Street address
Namazi square, Zand street
City
Shiraz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
CT-P-92-6683

Health conditions studied

1

Description of health condition studied
gastroesophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro- oesophageal reflux disease

Primary outcomes

1

Description
Symptom severity
Timepoint
Weekly
Method of measurement
Visual scale 0-10

2

Description
Quality of life
Timepoint
Every 2 weeks
Method of measurement
GERD quality of life standardized qustionnaire

Secondary outcomes

1

Description
Lower esophageal sphincter pessure
Timepoint
One month
Method of measurement
Mannometry

2

Description
Esophageal residual acid reflux
Timepoint
Monthly
Method of measurement
pH meter

Intervention groups

1

Description
Midodrine, tablet 5 mg, 3 timesper day for one month
Category
Treatment - Drugs

2

Description
Midodrine, tablet 2.5mg, 3 times per day for one month
Category
Treatment - Drugs

3

Description
Placebo, tablet, 3 times per day for one month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Endoscopy ward, Namazi hospital
Full name of responsible person
Dr Gholam Reza Sivandzadeh, GI fellowship
Street address
Endoscopy ward, Namazi hospital
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Sayyed Basir Hashemi
Street address
Namazi square- Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gastroenterohepatology research center
Full name of responsible person
Gholam Reza Sivandzadeh
Position
GI fellowship
Other areas of specialty/work
Street address
Gastroenterohepatology research center - Namazi hospital
City
Shiraz
Postal code
71935-1311
Phone
+98 71 1647 3236
Fax
Email
ghsivand@sums.ac.ir ; grc@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastroenterohepatology research center, Shiraz University of Medical Sciences
Full name of responsible person
Kamran Bagheri Lankarani
Position
Full professor
Other areas of specialty/work
Street address
Health policy research center- Shiraz medical school
City
Shiraz
Postal code
Phone
+98 71 1230 1596
Fax
Email
lankaran@sums.ac.ir; lankarani@mohme.gov.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Sivandzadeh
Position
GI fellowship
Other areas of specialty/work
Street address
Gastroenterohepathology research center- Namazi hospital- Zand street
City
Shiraz
Postal code
71935-1311
Phone
+98 71 1647 4263
Fax
Email
ghsivand@sums.ac.ir; grc@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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