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| ID | Type | Description | Link |
|---|---|---|---|
| PPI in SSc-GERD | Other Grant/Funding Number | Thai Rheumatism Association |
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The investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (GERD) in systemic sclerosis (SSc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant GERD in SSc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant GERD in SSc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omeprazole plus alginic acid and placebo of domperidone | Experimental |
| |
| Omeprazole plus domperidone and placebo of alginic acid | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginic acid | Drug | Algycon 1 tab chew tid after meal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) | VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment. | 8 weeks |
| Changing of the Severity of Regurgitation | VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) | Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment. | 8 weeks |
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Phase 1 SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 1 study for evaluation the prevalence of omeprazole resistant-GERD
Inclusion criteria:
Exclusion criteria:
Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study.
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chingching Foocharoen, MD | Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 123 Department of Medicine, Faculty of Medicine, Khon Kaen University | Khon Kaen | Changwat Khon Kaen | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27179107 | Derived | Foocharoen C, Chunlertrith K, Mairiang P, Mahakkanukrauh A, Suwannaroj S, Namvijit S, Wantha O, Nanagara R. Effectiveness of add-on therapy with domperidone vs alginic acid in proton pump inhibitor partial response gastro-oesophageal reflux disease in systemic sclerosis: randomized placebo-controlled trial. Rheumatology (Oxford). 2017 Feb;56(2):214-222. doi: 10.1093/rheumatology/kew216. Epub 2016 May 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omeprazole Plus Alginic Acid and Placebo of Domperidone | Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal |
| FG001 | Omeprazole Plus Domperidone and Placebo of Alginic Acid | Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Omeprazole Plus Alginic Acid and Placebo of Domperidone | Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal |
| BG001 | Omeprazole Plus Domperidone and Placebo of Alginic Acid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) | VAS scale 0-100 was applied for an outcome measurement of the severity of heart burn. The VAS scale 0 was no symptoms of heart burn and scale 100 was a maximum symptom of heart burn. The changing of the severity of heart burn was the changing of VAS before and after treatment. | Posted | Mean | Standard Deviation | VAS (100) | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Omeprazole Plus Alginic Acid and Placebo of Domperidone | Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | nausea | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Chingching Foocharoen | Khon Kaen University | 6643363746 | fching@kku.ac.th |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077322 | Alginic Acid |
| D004294 | Domperidone |
| ID | Term |
|---|---|
| D020723 | Glucuronic Acid |
| D005965 | Glucuronates |
| D014574 | Uronic Acids |
| D013400 | Sugar Acids |
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| placebo (for domperidone) | Drug | placebo (for domperidone) 1 tab oral tid before meal |
|
| Domperidone | Drug | domperidone (10 mg) 1 tab oral tid before meal |
|
|
| placebo (of alginic acid) | Drug | placebo (for alginic acid) 1 tab chew tid after meal |
|
| the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole | 4 weeks |
| Changing of the Quality of Life Which is Evaluated by EQ-5DTM | VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment. | 8 weeks |
Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
|
|
| Primary | Changing of the Severity of Regurgitation | VAS scale 0-100 was applied for an outcome measurement of the severity of regurgitation. The VAS scale 0 was no symptoms of regurgitation and scale 100 was a maximum symptom of regurgitation. The changing of the severity of regurgitation was the changing of VAS before and after treatment. | Posted | Mean | Standard Deviation | VAS (100) | 8 weeks |
|
|
|
| Secondary | Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) | Unit scale 0-48 was applied for an outcome measurement of the frequency of symptoms. The unit scale 0 was no symptom and scale 48 was usual symptom of GERD. The changing of the frequency of symptoms was the changing of the unit scale before and after treatment. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
|
|
| Secondary | the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole | The number of analysed patients came out the total number of screening patients in the trial. The patients who were defined as omeprazole-resistant GERD were enrolled and randomized for either alginic acid plus placebo or domperidone plus placebo group. | Posted | Number | 95% Confidence Interval | percentage of participants | 4 weeks |
|
|
|
| Secondary | Changing of the Quality of Life Which is Evaluated by EQ-5DTM | VAS scale 0-100 was applied for an outcome measurement of the quality of life. The VAS scale 0 was the worst quality of life and scale 100 was the best quality of life. The changing of the quality of life was the changing of VAS of quality of life before and after treatment. | Posted | Mean | Standard Deviation | VAS (100) | 8 weeks |
|
|
|
| 0 |
| 37 |
| 2 |
| 37 |
| EG001 | Omeprazole Plus Domperidone and Placebo of Alginic Acid | Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal | 0 | 38 | 2 | 38 |
| soft tissue infection | Infections and infestations | soft tissue infectio | Systematic Assessment |
|
| leg pain | Musculoskeletal and connective tissue disorders | leg pain | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006603 | Hexuronic Acids |
| D000145 | Acids, Aldehydic |
| D006880 | Hydroxy Acids |
| D000464 | Alginates |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |