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.
Trial 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… Read more about this study
- 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
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chingching Foocharoen, Khon Kaen University
- Investigators
- Chingching Foocharoen, MD, Principal investigator, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
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
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
- 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.
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.
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
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.
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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.