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Trial registered on ANZCTR


Registration number
ACTRN12613000910707
Ethics application status
Approved
Date submitted
11/08/2013
Date registered
15/08/2013
Date last updated
2/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of sustained release baclofen on alleviation of gastro-esophageal reflux disease symptoms
Scientific title
Effect of Baclofen sustained release vs placebo on alleviation of reflux symptoms in patients with Gastroesophageal reflux disease
Secondary ID [1] 283001 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophageal reflux disease 289828 0
Condition category
Condition code
Oral and Gastrointestinal 290185 290185 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Addition of oral tablet baclofen sustained release 10 mg twice daily or placebo twice daily for 1 months to the selective treatment of Gastroesophageal reflux disease in Iranian clinics(oral omeprazole 20 mg/d for 2 months). Baclofen/placebo and omeprazole will be start at the same time.
Adherence monitoring by pill count
Intervention code [1] 287716 0
Treatment: Drugs
Comparator / control treatment
placebo contains microcellulose tablet
Control group
Placebo

Outcomes
Primary outcome [1] 290215 0
alleviation of gastroesophagear reflux disesase symptoms by Mayo Gastro-esophageal Reflux questionnaire
Timepoint [1] 290215 0
1 month
Secondary outcome [1] 304123 0
alleviation of quality of life by SF-36 Quality of Life Questionnaire
Timepoint [1] 304123 0
1 month

Eligibility
Key inclusion criteria
patients with diagnosis of Gastroesophageal reflux disease on the basis of Rome 3 criteria
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.history of Hypersensivity to baclofen
2.renal or hepatic failure
3.Neurological diseases
4.pregnant women
5.breastfeeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5290 0
Iran, Islamic Republic Of
State/province [1] 5290 0
Tehran

Funding & Sponsors
Funding source category [1] 287768 0
University
Name [1] 287768 0
Shahid Beheshti University of Medical Sciences
Address [1] 287768 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran PO box: 14397-65461
Country [1] 287768 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University of Medical Sciences
Address
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran PO box: 14397-65461
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 286495 0
None
Name [1] 286495 0
Address [1] 286495 0
Country [1] 286495 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289715 0
Ethics commiittee, Shahid Beheshti University of Medical sciences
Ethics committee address [1] 289715 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran PO box: 14397-65462
Ethics committee country [1] 289715 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 289715 0
08/02/2013
Approval date [1] 289715 0
01/03/2013
Ethics approval number [1] 289715 0
576-98234

Summary
Brief summary
Proton Pump Inhibitors(PPIs) such as omeprazole are primary treatment for gastroesophageal reflux disease(GERD). Some patients do not cure adequetly with using PPIs. So we want to try effect of addition baclofen sustained release 10 mg twice daily vs placebo in addition to omeprazole 20 mg/d in both groups in alleviation of gastroesophageal reflux symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42098 0
Dr Mohammad Abbasinazari
Address 42098 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran, Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 42098 0
Iran, Islamic Republic Of
Phone 42098 0
+98 2188873704
Fax 42098 0
Email 42098 0
farshadpharm@yahoo.com
Contact person for public queries
Name 42099 0
Dr Mohammad Abbasinazari
Address 42099 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran, Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 42099 0
Iran, Islamic Republic Of
Phone 42099 0
+98 2188873704
Fax 42099 0
Email 42099 0
farshadpharm@yahoo.com
Contact person for scientific queries
Name 42100 0
Dr Mohammad Abbasinazari
Address 42100 0
Velenjak, near Talighani hospital, 3rd street, Tehran,Tehran, Iran, Shahid Beheshti University of Medical Sciences PO box: 14397-65461
Country 42100 0
Iran, Islamic Republic Of
Phone 42100 0
+98 2188873704
Fax 42100 0
Email 42100 0
farshadpharm@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary