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Comparison of distal esophageal spasm treatment with Diltiazem vs. Fluoxetine on clinical and monomeric findings

Protocol summary

Study aim
Comparison of Diltiazem with Fluoxetine treatment on clinical and monomeric findings of distal esophageal spasm
Design
Parallel group, double blind, randomized, phase 3 controlled trial on 80 patients. GraphPad software will be used for randomization.
Settings and conduct
The study will be performed on 80 patients referred to Taleghani Hospital in Tehran with the diagnosis of distal esophageal spasm based on manometry. Patients are divided into 2 groups of 40 people. The first group will be treated with fluoxetine 10 mg daily and omeprazole 20 mg every 12 hours for 2 months and the second group will be treated with diltiazem 30 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug.
Participants/Inclusion and exclusion criteria
Age more than 18 years All patients diagnosed as distal esophageal manometry according to manometry
Intervention groups
Intervention group 1: Fluoxetine 10 mg daily and omeprazole 20 mg twice daily for 2 months Intervention group 2: Diltiazem 30 mg daily and omeprazole 20 mg twice daily for 2 months
Main outcome variables
Improve clinical symptoms (chest pain, dysphagia), improve quality of life, improve findings of esophageal manometry

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220413054528N1
Registration date: 2022-06-22, 1401/04/01
Registration timing: registered_while_recruiting

Last update: 2022-06-22, 1401/04/01
Update count: 0
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
ahmad ghorbanpour rasekh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4222 0733
Email address
a_g_rassekh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of distal esophageal spasm treatment with Diltiazem vs. Fluoxetine on clinical and monomeric findings
Public title
Effect of diltiazem and fluoxetine on DES
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years All patients diagnosed as distal esophageal manometry according to manometry
Exclusion criteria:
1. Patients abusing drugs 2. Patients with systemic disorders including :Mastocytosis Systemic vasculitis, Sarcoidosis, Hypothyroidism, Diabetes mellitus, Fibromyalgia, Adrenal insufficiency, Coeliac disease, inflammatory bowel disease, Hypertension (high blood pressure), Metabolic syndrome, AIDS, Graves' disease, Systemic lupus erythematosus, Rheumatoid arthritis, Atherosclerosis, Sickle cell disease, Myasthenia gravis, Systemic Sclerosis, Sinusitis
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Based on sample size of study, 20 blocks with a size of 4 (such as AABB, ABAB, etc.) in a randomly varied order, will be used for random allocation. Random blocks will be provided by GraphPad software. The blocks will be placed one after the other in sequence, from the first to the 20th of them (equivalent to the first to the 80th patient). For example, if the blocks that will be provided by the software are AABB, BBAA, ABAB, respectively, the order of patients’ bowel preparation regimens will be AABBABABBBAA. The order of the blocks (20 provided blocks, it means arranging 80 drug regimens for 80 patients) will be reposed to the clinic secretary. Patients who will be diagnosed distal esophageal spasm based on manometry, and declare their informed consent to enter the study, will receive a drug regimen based on the provided blocks A or B, respectively.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gastroenterology and Liver Diseases Research Institute, Shahid Beheshti Universi
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Approval date
2021-07-19, 1400/04/28
Ethics committee reference number
IR.SBMU.RIGLD.REC.1400.015

Health conditions studied

1

Description of health condition studied
Distal esophageal spasm
ICD-10 code
K22.4
ICD-10 code description
Dyskinesia of esophagus

Primary outcomes

1

Description
Improvement of clinical manifestations (chest pain, dysphagia)
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Questionnaire of patients symptoms, Questionnaire of quality of life, Eckardt score, Psychological questionnaire HADS and SF-36, esophageal manometry

Secondary outcomes

1

Description
Improvement of esophageal manometric parameters
Timepoint
Before intervention and 2 months after intervention
Method of measurement
Esophageal manometry

Intervention groups

1

Description
The first group will be treated with fluoxetine 10 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug.
Category
Treatment - Drugs

2

Description
The second group will be treated with diltiazem 30 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Ahmad Ghorbanpour Rasekh
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9982
Email
a_g_rassekh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice-chancellor in research affairs, No 1, Shahid Beheshti university of medical sciences, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Ghorbanpour Rasekh
Position
Subspecialized assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, Shahid Beheshti University of Medical Scienc
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9982
Email
a_g_rassekh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Ghorbanpour Rasekh
Position
Subspecialized assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9982
Email
a_g_rassekh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ahmad Ghorbanpour Rasekh
Position
Subspecialized assistant
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9982
Email
a_g_rassekh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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