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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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7 October 2014 |
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Main ID: |
EUCTR2005-004155-35-BE |
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Date of registration:
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04/07/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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).
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Scientific title:
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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). |
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Date of first enrolment:
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28/07/2006 |
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Target sample size:
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24 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-004155-35 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Belgium
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Gastro-Esophageal Reflux Disease (GERD).
MedDRA version: 8.1
Level: LLT
Classification code 10018203
Term: GERD
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Intervention(s)
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Product Code: CJ-040,714
Pharmaceutical Form: Tablet
Current Sponsor code: CJ-040,714
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: CJ-040,714
Pharmaceutical Form: Tablet
Current Sponsor code: CJ-040,714
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: - To investigate the effect of CJ-040,714 on the duration of the longest acid reflux event.
- To investigate the effect of CJ-040,714 on the number of acid reflux events.
- To investigate the effect of CJ-040,714 on the number of acid reflux events > 5 minutes in length.
- To investigate the effect of CJ-040,714 on the esophageal clearance time of acid reflux events.
- To investigate the PK/PD relationship with regards to the primary endpoint.
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Main Objective: To investigate the effect of CJ-040,714 on the fraction of time that esophageal pH
is < 4.
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Primary end point(s): • Fraction of time pH < 4
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Secondary ID(s)
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A7421007
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2005-004155-35-GB
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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