Trials / Completed
CompletedNCT03284177
A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 89 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Calcium (13C)Carbonate | C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions. |
| DRUG | Gastric acid inhibitors | Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test. |
| OTHER | Gastric pH monitoring | Gastric pH monitoring was performed once under fasting condition. |
Timeline
- Start date
- 2017-10-31
- Primary completion
- 2018-12-04
- Completion
- 2018-12-04
- First posted
- 2017-09-15
- Last updated
- 2019-04-01
Locations
13 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03284177. Inclusion in this directory is not an endorsement.