Gastroesophageal Reflux DiseasePhase 2NCT03284177
A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
A Phase 2 study testing Calcium (13C)Carbonate, Gastric acid inhibitors and Gastric pH monitoring in people with Gastroesophageal Reflux Disease, run by Otsuka Pharmaceutical Co., Ltd. at 13 sites in Japan.
Trial summary
To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients Read more about this study
- Who is it for?
- Ages 20 to 89 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- Calcium (13C)Carbonate, Gastric acid inhibitors and Gastric pH monitoring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 13 sitesJapan
- Study dates
- 31 Oct 2017to 4 Dec 2018
- Phase
- Phase 2
- 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 20 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator.
Who cannot join
- Patients suspected to have hypothyroidism or hyperparathyroidism.
- Patients with hypercalcemia
- Patients with a history of gastric or duodenal surgery.
- Patients who have received the eradication therapy of Helicobacter pylori within six months prior to participation of the study.
- Patients with a prior or current history of Zollinger-Ellison syndrome.
- Patients with a history of surgery or treatment affecting gastroesophageal reflux.
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- Patients who have been diagnosed with acute upper gastrointestinal bleeding or active gastric or duodenal ulcer within 30 days prior to participation of the study.
- Patients with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyspraxia.
- Patients scheduled for surgery requiring hospitalization or required surgery during the study period.
- Patients who have had either a prior or current history of chest pain due to heart disease or with chest pain suspected to have caused by heart disease within one year prior to participation of the study.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Akita University Hospital
Akita
National Hospital Organization Hakodate Hospital
Hakodate
Shimane University Hospital
Izumo
Kawasaki Medical School General Medical Center
Kurashiki
Kawasaki Medical School Hospital
Kurashiki
National Hospital Organization Matsumoto Medical Center
Matsumoto
Hyogo College Of Medicine College Hospital
Nishinomiya
Osaka Saiseikai Nakatsu Hospital
Osaka
Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency
Tokyo
Hiratsuka stomach and intestines Hospital
Tokyo
Nippon Medical School Hospital
Tokyo
National Hospital Organization Yokohama Medical Center
Yokohama
Yokohama City University Hospital
Yokohama
About this study
Official title: A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients
To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- Calcium (13C)Carbonate, Gastric acid inhibitors, Gastric pH monitoring
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium (13C)CarbonateDrug
C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.
Gastric acid inhibitorsDrug
Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.
Gastric pH monitoringOther
Gastric pH monitoring was performed once under fasting condition.
| Study group | Role | What they receive |
|---|---|---|
| C13-CAC | Experimental | Not described Receives: Drug: Calcium (13C)Carbonate; Drug: Gastric acid inhibitors; Other: Gastric pH monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 concentration in expired air.
Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
Measured: 5，10，15，20，25 and 30 minutes after C13-CAC administration.
Secondary outcomes (1)
Gastric pH
Sensitivity and specificity of mean gastric pH for improvement of symptoms.
Measured: 1 hour prior to C13-CAC administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start31 Oct 2017
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284177
- Sponsor's protocol ID
- 334-103-00001
- Other IDs
- JapicCTI-173713
- Status last verified
- Mar 2019
- First submitted
- 11 Sep 2017
- Last updated
- 1 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients
- ClinicalTrials.gov ID
- NCT03284177
- Acronym / sponsor ID
- 334-103-00001
- Conditions
- Gastroesophageal Reflux Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 15 Sep 2017 (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.
To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C13-CAC | Experimental | Drug: Calcium (13C)Carbonate, Drug: Gastric acid inhibitors, Other: Gastric pH monitoring |
Who may qualify
- Ages
- 20 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator.
Key exclusion criteria (10 listed)
- Patients suspected to have hypothyroidism or hyperparathyroidism.
- Patients with hypercalcemia
- Patients with a history of gastric or duodenal surgery.
- Patients who have received the eradication therapy of Helicobacter pylori within six months prior to participation of the study.
- Patients with a prior or current history of Zollinger-Ellison syndrome.
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 |
|---|---|---|
| Calcium (13C)CarbonateC13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions. | Drug | C13-CAC |
| Gastric acid inhibitorsGastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test. | Drug | C13-CAC |
| Gastric pH monitoringGastric pH monitoring was performed once under fasting condition. | Other | C13-CAC |
Primary outcome
13CO2 concentration in expired air.
Time frame: 5，10，15，20，25 and 30 minutes after C13-CAC administration.
Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
1 secondary outcome
Gastric pH
Time frame: 1 hour prior to C13-CAC administration
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 1 Apr 2019.
- Individual participant dataSharing planned: No
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcium (13C)Carbonate, Gastric acid inhibitors and Gastric pH monitoring in people with Gastroesophageal Reflux Disease, run by Otsuka Pharmaceutical Co., Ltd. at 13 sites in Japan.
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 1 inclusion and 10 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 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
13CO2 concentration in expired air. (time frame: 5，10，15，20，25 and 30 minutes after C13-CAC administration.). 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 1 Apr 2019.