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Completed

NCT Number: NCT02225067

Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring

The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers

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Key information

Conditions

Gastric Acid-related Diseases Healthy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

OPHAC Hospital

Osaka, 532-0003, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal reflux disease in investigator's judgment
  • Healthy subjects who are determined no history of Helicobacter pylori infections

Exclusion criteria

  • Patients with hypercalcemia
  • Patients with hypothyroidism
  • Patients with hyperparathyroidism
  • History of upper gastrointestinal surgery or resection
  • Any condition would limit the subject's ability to complete 24-hour gastric pH monitoring

Treatment and study plan

Calcium (13C)Carbonate

Drug

Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate

Primary outcomes

  1. 13CO2 concentration in expired air

    Time frame: 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration

    13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air

  2. 24-hour gastric pH

    Time frame: from completion of pre-study examination to before C13-CAC adminitration

    Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration

Other outcomes

  1. Gastric pH holding time ratio

    Time frame: from completion of pre-study examination to before C13-CAC adminitration

    pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • EPS Corporation

Registry information

Official study title

Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 25, 2014
Registry last updated
May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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