Protocol summary
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Study aim
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Investigating the effect of sucralfate/sodium alginate capsules in patients with treatment-resistant gastroesophageal reflux disease (GERD)
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Design
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In this phase 3 comparative randomized clinical trial with parallel design, 492 patients will randomized to two active treatment groups (246 in each group). the control group receives a double dose of proton pump inhibitor for 8 weeks. The intervention group will recieve ALSUC capsules containing 500 mg sucralfate and 500 mg sodium alginate for 8 weeks.
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Settings and conduct
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The refractory GERD patients are divided into two intervention and control groups after randomization. Blinding in this study is single blind that the drug and comparative medication are labeled as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and also the person who is data analyzer does not know about this labeling. Patients are selected from Razi, Mostafa Khomeini, and Imam Khomeini hospitals in Ilam.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients who remained symptomatic (assessed by daily reflux questionnaire) with a standard dose of PPI after a trial period of treatment of at least 2 months.
Exclusion criteria: non-compliant; inappropriate use of PPI; Other diseases that can mimic the symptoms of GERD include achalasia, eosinophilic esophagitis, infectious esophagitis, pill esophagitis, gastroparesis; severe erosive GERD (Los Angeles classification grades C–D); Barrett’s esophagus; esophageal stricture or cancer; H. pylori infection; diabetes mellitus; advanced kidney impairment
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Intervention groups
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Control group will receive double dose of proton pump inhibitor.
intervention group receive ALSUC capsules containing 500 mg sucralfate and 500 mg sodium alginate.
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Main outcome variables
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Primary outcome is the percentage of complete heartburn free days.
General information
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Reason for update
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To Add missing items
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211203053263N3
Registration date:
2024-05-09, 1403/02/20
Registration timing:
registered_while_recruiting
Last update:
2025-03-19, 1403/12/29
Update count:
2
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Registration date
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2024-05-09, 1403/02/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-03-15, 1402/12/25
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Expected recruitment end date
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2025-03-15, 1403/12/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of capsules containing sucralfate/sodium alginate in patients with refractory gastroesophageal reflux disease
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Public title
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ALSUC in refractory GERD
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients who remained symptomatic (assessed by daily reflux questionnaire) with a standard dose of PPI after a trial period of treatment of at least 2 months.
Exclusion criteria:
non-compliant
inappropriate use of PPI
Other diseases that can mimic the symptoms of GERD include achalasia, eosinophilic esophagitis, infectious esophagitis, pill esophagitis, gastroparesis, severe erosive GERD (Los Angeles classification grades C–D), Barrett’s esophagus, esophageal stricture or cancer.
H. pylori infection
diabetes mellitus
advanced kidney impairment
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Age
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From 18 years old to 70 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
656
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Permuted Block Randomization will be used for random allocation. The size of the blocks will randomly selected. There are 4, random blocks, each has an equal number of interventions and controls. In the 4 blocks, two allocations are considered for the intervention group and two allocations for the control group. Random Allocation Software will be used for this purpose. The concealment will done using sequentially numbered, sealed envelopes.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Blinding in this study is double blind that the drug and comparative medication are labeled as "Group A" and "Group B". They are quite similar in appearance and the person participating in the study and also the person who is data analyzer does not know about this labeling.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-02-14, 1402/11/25
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Ethics committee reference number
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IR.MEDILAM.REC.1402.237
Health conditions studied
1
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Description of health condition studied
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GERD
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ICD-10 code
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K21
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ICD-10 code description
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Gastro-esophageal reflux disease
Primary outcomes
1
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Description
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percentage of complete heartburn-free days
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
Secondary outcomes
1
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Description
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Percentage of complete regurgitation-free days
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
2
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Description
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changes from baseline to week 8 in weekly heartburn severity score
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
3
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Description
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changes from baseline to week 8 in weekly regurgitation severity score.
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
4
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Description
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percentage of days without rescue antacid use over the treatment period.
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
5
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Description
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Time up to the first 24/48 hours without heartburn.
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
6
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Description
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Time up to the first 24/48 hours without regurgitation.
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Timepoint
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During intervention
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Method of measurement
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Questionnaire
7
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Description
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proportion of patients with complete resolution of heartburn at week 8
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Timepoint
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week 8
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Method of measurement
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Questionnaire
8
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Description
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proportion of patients with complete resolution of regurgitation at week 8
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Timepoint
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week 8
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: patients will receive cap ALSUC containing 500 mg sucralfate and 500 mg sodium alginate after each meal and at bedtime for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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Control group: the control group receive a double dose of Proton Pump Inhibitor before breakfast and dinner for 8 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ilam University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available