Trial Outcomes & Findings for Gastroesophageal Reflux Treatment in Scleroderma (NCT NCT01878526)
NCT ID: NCT01878526
Last Updated: 2017-03-27
Results Overview
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.
COMPLETED
PHASE3
80 participants
8 weeks
2017-03-27
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gastroesophageal Reflux Treatment in Scleroderma
Baseline characteristics by cohort
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=37 Participants
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
Omeprazole Plus Domperidone and Placebo of Alginic Acid
n=38 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
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.6 years
STANDARD_DEVIATION 9.5 • n=99 Participants
|
46.7 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
48.9 years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Region of Enrollment
Thailand
|
37 participants
n=99 Participants
|
38 participants
n=107 Participants
|
75 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksVAS 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.
Outcome measures
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=37 Participants
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
Omeprazole Plus Domperidone and Placebo of Alginic Acid
n=38 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
|
|---|---|---|
|
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
|
17.2 VAS (100)
Standard Deviation 13.9
|
PRIMARY outcome
Timeframe: 8 weeksVAS 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.
Outcome measures
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=37 Participants
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
Omeprazole Plus Domperidone and Placebo of Alginic Acid
n=38 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
|
|---|---|---|
|
Changing of the Severity of Regurgitation
|
24.9 VAS (100)
Standard Deviation 15.9
|
23.1 VAS (100)
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: 8 weeksUnit 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.
Outcome measures
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=37 Participants
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
Omeprazole Plus Domperidone and Placebo of Alginic Acid
n=38 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
|
|---|---|---|
|
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
|
4.7 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
Outcome measures
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=148 Participants
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
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
|
|---|---|---|
|
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
|
59 percentage of participants
Interval 51.0 to 67.0
|
—
|
SECONDARY outcome
Timeframe: 8 weeksVAS 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.
Outcome measures
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=37 Participants
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
Omeprazole Plus Domperidone and Placebo of Alginic Acid
n=38 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
|
|---|---|---|
|
Changing of the Quality of Life Which is Evaluated by EQ-5DTM
|
75.7 VAS (100)
Standard Deviation 15.8
|
76.1 VAS (100)
Standard Deviation 14.4
|
Adverse Events
Omeprazole Plus Alginic Acid and Placebo of Domperidone
Omeprazole Plus Domperidone and Placebo of Alginic Acid
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omeprazole Plus Alginic Acid and Placebo of Domperidone
n=37 participants at risk
Alginic acid: Algycon 1 tab chew tid after meal
placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal
|
Omeprazole Plus Domperidone and Placebo of Alginic Acid
n=38 participants at risk
Domperidone: domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/37
|
2.6%
1/38 • Number of events 1
|
|
Infections and infestations
soft tissue infection
|
2.7%
1/37 • Number of events 1
|
2.6%
1/38 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
leg pain
|
2.7%
1/37 • Number of events 1
|
0.00%
0/38
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place