Gastroesophageal Reflux Disease, Scleroderma, Systemic Sclerosis
Conditions
Keywords
gastroesophageal reflux disease, heart burn, regurgitation, systemic sclerosis, scleroderma, proton pump inhibitor, alginic acid, omeprazole, prokinetic
Brief summary
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.
Interventions
DRUGAlginic acid
Algycon 1 tab chew tid after meal
DRUGplacebo (for domperidone)
placebo (for domperidone) 1 tab oral tid before meal
DRUGDomperidone
domperidone (10 mg) 1 tab oral tid before meal
DRUGplacebo (of alginic acid)
placebo (for alginic acid) 1 tab chew tid after meal
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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: 1. SSc patients aged between 18 and 65 years. 2. Clinically diagnosed as GERD and GERD-questionnaire score \>3 3. Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) | 8 weeks | 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. |
| Changing of the Severity of Regurgitation | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) | 8 weeks | 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. |
| 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 | 8 weeks | 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. |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| 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 | 38 |
| Total | 75 |
Baseline characteristics
| Characteristic | Omeprazole Plus Alginic Acid and Placebo of Domperidone | Omeprazole Plus Domperidone and Placebo of Alginic Acid | Total |
|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 9.5 | 46.7 years STANDARD_DEVIATION 12.5 | 48.9 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment Thailand | 37 participants | 38 participants | 75 participants |
| Sex: Female, Male Female | 17 Participants | 30 Participants | 47 Participants |
| Sex: Female, Male Male | 20 Participants | 8 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 37 | 2 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeprazole Plus Alginic Acid and Placebo of Domperidone | Changing of the Severity of Regurgitation | 24.9 VAS (100) | Standard Deviation 15.9 |
| Omeprazole Plus Domperidone and Placebo of Alginic Acid | Changing of the Severity of Regurgitation | 23.1 VAS (100) | Standard Deviation 15.1 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeprazole Plus Alginic Acid and Placebo of Domperidone | Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) | 17.9 VAS (100) | Standard Deviation 13.1 |
| Omeprazole Plus Domperidone and Placebo of Alginic Acid | Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) | 17.2 VAS (100) | Standard Deviation 13.9 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeprazole Plus Alginic Acid and Placebo of Domperidone | Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) | 4.6 units on a scale | Standard Deviation 3.3 |
| Omeprazole Plus Domperidone and Placebo of Alginic Acid | Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG) | 4.7 units on a scale | Standard Deviation 3.7 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omeprazole Plus Alginic Acid and Placebo of Domperidone | Changing of the Quality of Life Which is Evaluated by EQ-5DTM | 75.7 VAS (100) | Standard Deviation 15.8 |
| Omeprazole Plus Domperidone and Placebo of Alginic Acid | Changing of the Quality of Life Which is Evaluated by EQ-5DTM | 76.1 VAS (100) | Standard Deviation 14.4 |
Secondary
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Omeprazole Plus Alginic Acid and Placebo of Domperidone | the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole | 59 percentage of participants |