NCT03284177

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2018

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

September 11, 2017

Last Update Submit

March 28, 2019

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • 13CO2 concentration in expired air.

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

    5，10，15，20，25 and 30 minutes after C13-CAC administration.

Secondary Outcomes (1)

  • Gastric pH

    1 hour prior to C13-CAC administration

Study Arms (1)

C13-CAC

EXPERIMENTAL
Drug: Calcium (13C)CarbonateDrug: Gastric acid inhibitorsOther: Gastric pH monitoring

Interventions

Calcium (13C)CarbonateDRUG

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

C13-CAC
Gastric acid inhibitorsDRUG

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

C13-CAC
Gastric pH monitoringOTHER

Gastric pH monitoring was performed once under fasting condition.

C13-CAC

Eligibility Criteria

Age20 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Akita University Hospital

Akita, Japan

Location

National Hospital Organization Hakodate Hospital

Hakodate, Japan

Location

Shimane University Hospital

Izumo, Japan

Location

Kawasaki Medical School General Medical Center

Kurashiki, Japan

Location

Kawasaki Medical School Hospital

Kurashiki, Japan

Location

National Hospital Organization Matsumoto Medical Center

Matsumoto, Japan

Location

Hyogo College Of Medicine College Hospital

Nishinomiya, Japan

Location

Osaka Saiseikai Nakatsu Hospital

Osaka, Japan

Location

Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency

Tokyo, Japan

Location

Hiratsuka stomach and intestines Hospital

Tokyo, Japan

Location

Nippon Medical School Hospital

Tokyo, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Japan

Location

Yokohama City University Hospital

Yokohama, Japan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Calcium

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 15, 2017

Study Start

October 31, 2017

Primary Completion

December 4, 2018

Study Completion

December 4, 2018

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

JP(13)