Systemic SclerosisPhase 1NCT03561233
Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis
A Phase 1 study testing Omeprazole 20mg in people with Systemic Sclerosis and Gastroesophageal Reflux, run by Khon Kaen University.
Trial summary
Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Gastroesophageal Reflux, Proton Pubm Inhibitor
- What is being tested?
- Omeprazole 20mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jun 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- 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
- Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation
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
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- 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
About this study
Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.
- Being tested
- Omeprazole 20mg
- Medical subject headings
- Scleroderma, Systemic, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole 20mgDrug
omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| proton pump inhibitor | Experimental | omeprazole 20 mg twice daily Receives: Drug: Omeprazole 20mg |
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 GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc 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. PPI-PR GERD is defined when the changing of severity of heart burn is improvement less than 50% compare to baseline.
Measured: 4 weeks
Changing of Frequency of Symptoms in SSc related 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. PPI-PR GERD is defined when the changing of frequency of symptom in SSc related GERD evaluated by FSSG is improvement less than 50% compare to baseline.
Measured: 4 weeks
Secondary outcomes (6)
The proportion of participant with diffuse cutaneous SSc (dcSSc) subset between the patient who response to omeprazole and partial response to omeprazole,
The number of dcSSc subset in the patient who response to omeprazole and partial response to omeprazole, DcSSc is defined as yes or no when the patient has skin tightness includes trunk and both extremities and not include trunk and extremities, respectively.
Measured: 4 weeks
The proportion of participant with esophageal dysphagia between the patient who response to omeprazole and partial response to omeprazole,
The number of dysphagia in the patients who response to omeprazole and partial response to omeprazole. Esophageal dysphagia is defined as yes or no when the patients has dysphagia and no dysphagia symptom, respectively.
Measured: 4 weeks
The proportion of participant with female gender between the patient who response to omeprazole and partial response to omeprazole
The number of female gender in the patients who response to omeprazole and partial response to omeprazole. Female gender is defined as yes or no when the patient is female and male, respectively.
Measured: 4 weeks
The proportion of participant with age>60 years between the patient who response to omeprazole and partial response to omeprazole
The number of age>60 years in the patients who response to omeprazole and partial response to omeprazole. Age>60 is defined as yes or no when the patient has age>60 and equal or less than 60 years, respectively.
Measured: 4 weeks
The proportion of participant with modified Rodnan skin score (mRSS)>20 between the patient who response to omeprazole and partial response to omeprazole
The number of mRSS>20 in the patients who response to omeprazole and partial response to omeprazole. The mRSS was assessed at 17 sites; viz., the face, chest, abdomen, arms, forearms, hands, fingers, thighs, legs and feet. Assessment was rated as 0 (normal skin thickness), 1 (mild but definite skin thickness), 2 (moderate thickness), or 3 (sever thickness with inability to pinch a fold of skin). The score was calculated by summing the rating score from all 17 areas (range, 0-51). mRSS> 20 is defined as yes or no when the patient has mRSS>20 and equal or less than 20, respectively.
Measured: 4 weeks
The proportion of participant with serum anti-topoisomerase I antibody positive between the patient who response to omeprazole and partial response to omeprazole
The number of anti-topoisomerase I positive in the patients who response to omeprazole and partial response to omeprazole. Serum anti-topoisomerase I antibody is defined as yes or no when the antibody in serum was positive and negative, respectively.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study startMay 2013
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Collaborators
- Thai Rheumatism Association
- Responsible party
- Principal investigator, Chingching Foocharoen, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561233
- Sponsor's protocol ID
- PPI partial response GERD SSc
- Status last verified
- Jun 2018
- First submitted
- 7 Jun 2018
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03561233
- Acronym / sponsor ID
- PPI partial response GERD SSc
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Collaborators
- Thai Rheumatism Association
- Study start
- May 2013 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proton pump inhibitor (PPI) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (GERD)-is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proton pump inhibitor | Experimental | Drug: Omeprazole 20mgomeprazole 20 mg twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- SSc patients aged between 18 and 65 years.
- Clinically diagnosed as GERD
- Must not receive any PPI or prokinetic drug within 2 weeks before baseline evaluation
Key exclusion criteria (9 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 |
|---|---|---|
| Omeprazole 20mgomeprazole 20 mg twice daily 30 minutes before meal for 4 weeks | Drug | proton pump inhibitor |
Primary outcome
Changing severity of heart burn of SSc related GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc Evaluated by Visual Analogue Score (VAS)
Time frame: 4 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. PPI-PR GERD is defined when the changing of severity of heart burn is improvement less than 50% compare to baseline.
Changing of Frequency of Symptoms in SSc related GERD Evaluated by Frequency Scale for the Symptoms of GERD (FSSG)
Time frame: 4 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. PPI-PR GERD is defined when the changing of frequency of symptom in SSc related GERD evaluated by FSSG is improvement less than 50% compare to baseline.
6 secondary outcomes
The proportion of participant with diffuse cutaneous SSc (dcSSc) subset between the patient who response to omeprazole and partial response to omeprazole,
Time frame: 4 weeks
The proportion of participant with esophageal dysphagia between the patient who response to omeprazole and partial response to omeprazole,
Time frame: 4 weeks
The proportion of participant with female gender between the patient who response to omeprazole and partial response to omeprazole
Time frame: 4 weeks
The proportion of participant with age>60 years between the patient who response to omeprazole and partial response to omeprazole
Time frame: 4 weeks
The proportion of participant with modified Rodnan skin score (mRSS)>20 between the patient who response to omeprazole and partial response to omeprazole
Time frame: 4 weeks
The proportion of participant with serum anti-topoisomerase I antibody positive between the patient who response to omeprazole and partial response to omeprazole
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole 20mg in people with Systemic Sclerosis and Gastroesophageal Reflux, run by Khon Kaen University.
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 3 inclusion and 9 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 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 GERD evaluated by visual analogue score (VAS) Changing Severity of Heart Burn of SSc Evaluated by Visual Analogue Score (VAS) (time frame: 4 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?
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 21 Jun 2018.