GERD-SSc: Gastroesophageal Reflux Treatment in Scleroderma

• Sponsor: Khon Kaen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01878526
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 31
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease; Systemic Sclerosis; Scleroderma	Drug: Alginic acid; Drug: placebo (for domperidone); Drug: Domperidone; Drug: placebo (of alginic acid)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omeprazole plus alginic acid and placebo of domperidone	Drug: Alginic acid; Algycon 1 tab chew tid after meal; Other Names: Algycon ; Drug: placebo (for domperidone); placebo (for domperidone) 1 tab oral tid before meal
Experimental: Omeprazole plus domperidone and placebo of alginic acid	Drug: Domperidone; domperidone (10 mg) 1 tab oral tid before meal; Other Names: Molax ; Drug: placebo (of alginic acid); placebo (for alginic acid) 1 tab chew tid after meal

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole [4 weeks]

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Exclusion criteria:

1. Pregnancy or lactation

2. Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis

3. Present of Barrett's esophagus

4. Bedridden and confined to no self-care

5. Evidence of active malignant disease

6. Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases

7. Present of active infection that needs systemic antibiotic

8. Allergic history of omeprazole

9. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate

Phase 2 randomized parallel study SSc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study.

Inclusion criteria:

1. SSc patients who completed the phase 1 study.

2. The subjects were defined as PPI-resistance.

3. The subject must be willing to continue phase 2 study.

Exclusion criteria:

1. Pregnancy

2. Present of uncontrolled or severe medical problems

3. Present of active infection

4. Allergic history of alginic acid or domperidone

5. Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate

6. Chewing difficulty

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	123 Department of Medicine, Faculty of Medicine, Khon Kaen University	Khon Kaen		Thailand	40002

Sponsors and Collaborators

• Khon Kaen University

Investigators

• Principal Investigator: Chingching Foocharoen, MD, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chingching Foocharoen, Associate Professor, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT01878526
• Other Study ID Numbers: GERD therapy in scleroderma; PPI in SSc-GERD
• First Posted: Jun 17, 2013
• Last Update Posted: Mar 27, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Chingching Foocharoen, Associate Professor, Khon Kaen University: gastroesophageal reflux disease; heart burn; regurgitation; systemic sclerosis; scleroderma; proton pump inhibitor; alginic acid; omeprazole; prokinetic
• Additional relevant MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis; Domperidone

Study Results

Participant Flow

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone	Omeprazole Plus Domperidone and Placebo of Alginic Acid
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal	Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
Period Title: Overall Study
STARTED	40	40
COMPLETED	37	38
NOT COMPLETED	3	2

Baseline Characteristics

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone	Omeprazole Plus Domperidone and Placebo of Alginic Acid	Total
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal	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 of all reporting groups
Overall Participants	37	38	75
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.6 (9.5)	46.7 (12.5)	48.9 (10.3)
Sex: Female, Male (Count of Participants)
Female	17 45.9%	30 78.9%	47 62.7%
Male	20 54.1%	8 21.1%	28 37.3%
Region of Enrollment (participants) [Number]
Thailand	37 100%	38 100%	75 100%

Outcome Measures

1. Primary Outcome

Title	Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone	Omeprazole Plus Domperidone and Placebo of Alginic Acid
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal	Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
Measure Participants	37	38
Mean (Standard Deviation) [VAS (100)]	17.9 (13.1)	17.2 (13.9)

2. Primary Outcome

Title	Changing of the Severity of Regurgitation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone	Omeprazole Plus Domperidone and Placebo of Alginic Acid
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal	Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
Measure Participants	37	38
Mean (Standard Deviation) [VAS (100)]	24.9 (15.9)	23.1 (15.1)

3. Secondary Outcome

Title	Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone	Omeprazole Plus Domperidone and Placebo of Alginic Acid
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal	Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
Measure Participants	37	38
Mean (Standard Deviation) [units on a scale]	4.6 (3.3)	4.7 (3.7)

4. Secondary Outcome

Title	the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

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/Group Title	Overall Systemic Sclerosis With GERD (Before Randomization)
Arm/Group Description	omeprazole 20 mg bid ac for 4 weeks for overall systemic sclerosis with GERD
Measure Participants	148
Number (95% Confidence Interval) [percentage of participants]	59 159.5%

5. Secondary Outcome

Title	Changing of the Quality of Life Which is Evaluated by EQ-5DTM
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone	Omeprazole Plus Domperidone and Placebo of Alginic Acid
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal	Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
Measure Participants	37	38
Mean (Standard Deviation) [VAS (100)]	75.7 (15.8)	76.1 (14.4)

Adverse Events

Arm/Group Title	Omeprazole Plus Alginic Acid and Placebo of Domperidone		Omeprazole Plus Domperidone and Placebo of Alginic Acid
Arm/Group Description	Alginic acid: Algycon 1 tab chew tid after meal placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal		Domperidone: domperidone (10 mg) 1 tab oral tid before meal placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal
All Cause Mortality
	Omeprazole Plus Alginic Acid and Placebo of Domperidone		Omeprazole Plus Domperidone and Placebo of Alginic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omeprazole Plus Alginic Acid and Placebo of Domperidone		Omeprazole Plus Domperidone and Placebo of Alginic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/37 (0%)		0/38 (0%)
Other (Not Including Serious) Adverse Events
	Omeprazole Plus Alginic Acid and Placebo of Domperidone		Omeprazole Plus Domperidone and Placebo of Alginic Acid
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/37 (5.4%)		2/38 (5.3%)
Gastrointestinal disorders
nausea	0/37 (0%)	0	1/38 (2.6%)	1
Infections and infestations
soft tissue infection	1/37 (2.7%)	1	1/38 (2.6%)	1
Musculoskeletal and connective tissue disorders
leg pain	1/37 (2.7%)	1	0/38 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.