A randomized, double blind, parallel group study to examine the effect of multiple doses of CJ-040,714 on distal esophageal acid exposure in patients with erosive gastro-esophageal reflux disease (gerd).
- Conditions
- Gastro-Esophageal Reflux Disease (GERD).MedDRA version: 8.1Level: LLTClassification code 10018203Term: GERD
- Registration Number
- EUCTR2005-004155-35-BE
- Lead Sponsor
- Pfizer Global Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Male or female (non-child bearing potential) subject aged 18 to 70 years inclusive.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Subjects with a history of significant cardiovascular disease, e.g. ischemic heart disease, arrhythmias, QT prolongation, MI or stroke.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of CJ-040,714 on the fraction of time that esophageal pH <br>is < 4.;Secondary Objective: - To investigate the effect of CJ-040,714 on the duration of the longest acid reflux event.<br>- To investigate the effect of CJ-040,714 on the number of acid reflux events.<br>- To investigate the effect of CJ-040,714 on the number of acid reflux events > 5 minutes in length.<br>- To investigate the effect of CJ-040,714 on the esophageal clearance time of acid reflux events.<br>- To investigate the PK/PD relationship with regards to the primary endpoint.;Primary end point(s): • Fraction of time pH < 4<br>
- Secondary Outcome Measures
Name Time Method