Gastroesophageal Reflux DiseasePhase 3GERD-SScNCT01878526

Gastroesophageal Reflux Treatment in Scleroderma

A Phase 3 study testing Alginic acid and Domperidone in people with Gastroesophageal Reflux Disease and Systemic Sclerosis, run by Khon Kaen University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Gastroesophageal Reflux Disease, Systemic Sclerosis, Scleroderma
What is being tested?: Alginic acid and Domperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteThailand
Study dates: Jun 2013to Jan 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

SSc patients aged between 18 and 65 years.
Clinically diagnosed as GERD and GERD-questionnaire score >3
Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation
SSc patients who completed the phase 1 study.
The subjects were defined as PPI-resistance.
The subject must be willing to continue phase 2 study.

Who cannot join

Pregnancy or lactation
Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
Present of Barrett's esophagus
Bedridden and confined to no self-care
Evidence of active malignant disease
Present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases

Show all 16Show fewer

Present of active infection that needs systemic antibiotic
Allergic history of omeprazole
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.
Pregnancy
Present of uncontrolled or severe medical problems
Present of active infection
Allergic history of alginic acid or domperidone
Receiving prohibit co-medications that may have drug interaction or attenuate GERD symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
Chewing difficulty

Trial locations and contacts

1 site in 1 country.

Thailand1 site

123 Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002

Other trials in Thailand

About this study

Official title: The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis

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.

Conditions: Gastroesophageal Reflux Disease, Systemic Sclerosis, Scleroderma
Being tested: Alginic acid, placebo (for domperidone), Domperidone, placebo (of alginic acid)
Keywords: gastroesophageal reflux disease, heart burn, regurgitation, systemic sclerosis, scleroderma, proton pump inhibitor, alginic acid, omeprazole, prokinetic
Medical subject headings: Gastroesophageal Reflux, Scleroderma, Systemic, Scleroderma, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alginic acidDrug
Also called Algycon
Algycon 1 tab chew tid after meal
placebo (for domperidone)Drug
placebo (for domperidone) 1 tab oral tid before meal
DomperidoneDrug
Also called Molax
domperidone (10 mg) 1 tab oral tid before meal
placebo (of alginic acid)Drug
placebo (for alginic acid) 1 tab chew tid after meal

Study groups in NCT01878526
Study group	Role	What they receive
Omeprazole plus alginic acid and placebo of domperidone	Experimental	Not described Receives: Drug: Alginic acid; Drug: placebo (for domperidone)
Omeprazole plus domperidone and placebo of alginic acid	Experimental	Not described Receives: Drug: Domperidone; Drug: placebo (of alginic acid)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (3)

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.
Measured: 8 weeks
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Jan 2016

First posted17 Jun 2013 (estimated)
Study startJun 2013
Primary completionAug 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01878526
Sponsor's protocol ID: GERD therapy in scleroderma
Other IDs: PPI in SSc-GERD
Acronym: GERD-SSc
Status last verified: Feb 2017
First submitted: 7 Jun 2013
Last updated: 27 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 27179107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All Gastroesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Domperidone Versus Alginic Acid Add on Omeprazole Therapy in Omeprazole Resistance Gastroesophageal Reflux in Systemic Sclerosis
ClinicalTrials.gov ID: NCT01878526
Acronym / sponsor ID: GERD-SSc / GERD therapy in scleroderma
Conditions: Gastroesophageal Reflux Disease, Systemic Sclerosis, Scleroderma
Keywords: gastroesophageal reflux disease, heart burn, regurgitation, systemic sclerosis, scleroderma, proton pump inhibitor, alginic acid, omeprazole
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Khon Kaen UniversityUniversity, hospital or other
Study start: Jun 2013
Primary completion: Aug 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 17 Jun 2013 (estimated)
Results: Posted 27 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Omeprazole plus alginic acid and placebo of domperidone	Experimental	Drug: Alginic acid, Drug: placebo (for domperidone)
Omeprazole plus domperidone and placebo of alginic acid	Experimental	Drug: Domperidone, Drug: placebo (of alginic acid)

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

SSc patients aged between 18 and 65 years.
Clinically diagnosed as GERD and GERD-questionnaire score >3
Must not receive any proton pump inhibitor (PPI) or prokinetic drug within 2 weeks before baseline evaluation
SSc patients who completed the phase 1 study.
The subjects were defined as PPI-resistance.

Key exclusion criteria (16 listed)

Pregnancy or lactation
Previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis
Present of Barrett's esophagus
Bedridden and confined to no self-care
Evidence of active malignant disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Alginic acidAlso: AlgyconAlgycon 1 tab chew tid after meal	Drug	Omeprazole plus alginic acid and placebo of domperidone
placebo (for domperidone)placebo (for domperidone) 1 tab oral tid before meal	Drug	Omeprazole plus alginic acid and placebo of domperidone
DomperidoneAlso: Molaxdomperidone (10 mg) 1 tab oral tid before meal	Drug	Omeprazole plus domperidone and placebo of alginic acid
placebo (of alginic acid)placebo (for alginic acid) 1 tab chew tid after meal	Drug	Omeprazole plus domperidone and placebo of alginic acid

Primary outcome

Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)
Time frame: 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
Time frame: 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.

3 secondary outcomes

Changing of Frequency of Symptoms in SSc Related Omeprazole Resistant GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
Time frame: 8 weeks
the Prevalence of Omeprazole-resistant GERD in SSc After 4 Weeks Treatment With Omeprazole
Time frame: 4 weeks
Changing of the Quality of Life Which is Evaluated by EQ-5DTM
Time frame: 8 weeks

Results and safety

Results posted to the registry on 27 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omeprazole Plus Alginic Acid and Placebo of Domperidone	40	37
Omeprazole Plus Domperidone and Placebo of Alginic Acid	40	38

Primary outcome: Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS)

Time frame: 8 weeks. Mean (Standard Deviation). Unit: VAS (100)

Measure	Omeprazole Plus Alginic Acid and Placebo of Domperidone n = 37	Omeprazole Plus Domperidone and Placebo of Alginic Acid n = 38
Value	17.9 (13.1)	17.2 (13.9)

Primary outcome: Changing of the Severity of Regurgitation

Time frame: 8 weeks. Mean (Standard Deviation). Unit: VAS (100)

Measure	Omeprazole Plus Alginic Acid and Placebo of Domperidone n = 37	Omeprazole Plus Domperidone and Placebo of Alginic Acid n = 38
Value	24.9 (15.9)	23.1 (15.1)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omeprazole Plus Alginic Acid and Placebo of Domperidone	0 of 37 (0%)	2 of 37 (5.4%)	Not reported
Omeprazole Plus Domperidone and Placebo of Alginic Acid	0 of 38 (0%)	2 of 38 (5.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27179107Foocharoen 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.

Related trials for Gastroesophageal Reflux Disease

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chingching Foocharoen, MD principal investigator

Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alginic acid and Domperidone in people with Gastroesophageal Reflux Disease and Systemic Sclerosis, run by Khon Kaen University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changing Severity of Heart Burn of SSc Related Omeprazole Resistant GERD Evaluated by Visual Analogue Score (VAS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01878526, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.