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Evaluating the effect of Gabapentin in improving symptoms of functional dyspeptic patients resistant to routine treatments

Protocol summary

Study aim
Determination of the effect of oral gabapentin on the improvement of symptoms in patients with functional dyspepsia resistant to conventional treatments
Design
In this study, 126 patients with dyspepsia with inclusion criteria are divided into two groups.control and intravention group, the control group receive only the routine treatment, 20 mg of omeprazole daily plus placebo per day, and the intervention group receive in addition to routine drugs, 20 mg omeprazole, 300 mg of gabapentin twice daily. after four weeks the therapeutic effects of the capsule of gabapantine will be examined.
Settings and conduct
Clinical trial; Gastrointestinal clinic; placebo-controlled
Participants/Inclusion and exclusion criteria
Inclusion criteria: Confirmation of functional dyspepsia diagnosis based on Roman criteria Exclusion criteria:Sensitivity to gabapentin,Serious side effect of gabapentin
Intervention groups
Intervention group:receive one capsule of 300 mg for 3 nights and then 300 mg twice a day
Main outcome variables
Diarrhea, constipation, indigestion, abdominal pain, nausea

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120709010222N19
Registration date: 2018-09-18, 1397/06/27
Registration timing: prospective

Last update: 2018-09-18, 1397/06/27
Update count: 0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Gabapentin in improving symptoms of functional dyspeptic patients resistant to routine treatments
Public title
Evaluating the effect of Gabapentin in improving symptoms of functional dyspeptic patients resistant to routine treatments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of functional dyspepsia diagnosis
Exclusion criteria:
Sensitivity to gabapentin, Serious side effect of gabapentin
Age
From 40 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified Random Sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the patient will have no information about the content of the capsules
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
88187187
Approval date
2017-07-01, 1396/04/10
Ethics committee reference number
IR.SKUMS.REC.1396.8

Health conditions studied

1

Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia

Primary outcomes

1

Description
Gastrointestinal symptoms
Timepoint
Four weeks later
Method of measurement
questionaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In addition to 20 mg omeprazole,receive 300 mg of gabapentin is given twice a day
Category
Treatment - Drugs

2

Description
Control group: only receive routine treatment, that is, daily 20 mg of omeprazole plus placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
بیمارستان کاشانی
Full name of responsible person
محمدهادی شفیق
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718796
Phone
+98 38 3222 0016
Email
Mhshafigh@skums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818618695
Phone
+98 38 3334 2414
Email
salati@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammadhadi Shafigh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718796
Phone
+98 38 3222 0016
Email
Mhshafigh@skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mohammdhadi Shafigh
Position
استادیار
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818718786
Phone
+98 38 3222 0016
Email
Mhshafigh@skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mhammadhadi Shafigh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Parastar street, Kashani Hospital of Shahrekord University of Medical Sciences, Shahrekord
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818618696
Phone
+98 38 3222 0016
Email
Mhshafigh@skums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data in article format
When the data will become available and for how long
2018
To whom data/document is available
researcher
Under which criteria data/document could be used
article
From where data/document is obtainable
journals
What processes are involved for a request to access data/document
publication of article
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