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CompletedNCT03284177Updated Apr 1, 2019

A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients

A Phase 2 interventional study of Calcium (13C)Carbonate and Gastric acid inhibitors in Gastroesophageal Reflux Disease, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 13 sites in Japan. Open to participants aged 20 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-04-01.

Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
20 Years to 89 Years
Sex
All
01

Study 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

02

Conditions studied

  • Gastroesophageal Reflux Disease
03

In context

Gastroesophageal Reflux

1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.

This study's enrollment of 55 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.

Browse Otsuka Pharmaceutical Co., Ltd. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • GERD patients who have been judged to require additional treatment to improve their symptoms by investigator or subinvestigator.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (actual)

Study arms

  • Experimental
    C13-CAC

    Drug: Calcium (13C)Carbonate · Drug: Gastric acid inhibitors · Other: Gastric pH monitoring

Interventions

  • DrugCalcium (13C)Carbonate

    C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.

  • DrugGastric acid inhibitors

    Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.

  • OtherGastric pH monitoring

    Gastric pH monitoring was performed once under fasting condition.

06

What researchers measure

Primary outcomes

  1. 13CO2 concentration in expired air.

    Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.

    Time frame: 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.

    Time frame: 1 hour prior to C13-CAC administration

07

Study locations

13 sites
  • Akita University Hospital
    Akita, Japan
  • National Hospital Organization Hakodate Hospital
    Hakodate, Japan
  • Shimane University Hospital
    Izumo, Japan
  • Kawasaki Medical School General Medical Center
    Kurashiki, Japan
  • Kawasaki Medical School Hospital
    Kurashiki, Japan
  • National Hospital Organization Matsumoto Medical Center
    Matsumoto, Japan
  • Hyogo College Of Medicine College Hospital
    Nishinomiya, Japan
  • Osaka Saiseikai Nakatsu Hospital
    Osaka, Japan
  • Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency
    Tokyo, Japan
  • Hiratsuka stomach and intestines Hospital
    Tokyo, Japan
  • Nippon Medical School Hospital
    Tokyo, Japan
  • National Hospital Organization Yokohama Medical Center
    Yokohama, Japan
  • Yokohama City University Hospital
    Yokohama, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Dec 2018, 13 months.

Of 14 phase 2 interventional studies under Gastroesophageal Reflux, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's 13 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 15, 2017
StartActual
Oct 31, 2017
Primary completionActual
Dec 4, 2018
CompletionActual
Dec 4, 2018
Last update
Apr 1, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03284177
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 15, 2017
Start date
Oct 31, 2017
Primary completion
Dec 4, 2018
Completion
Dec 4, 2018
Last update
Apr 1, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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