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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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25 November 2019 |
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Main ID: |
EUCTR2005-004155-35-GB |
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Date of registration:
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21/09/2005 |
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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 an patients with erosive gastro-esophageal reflux disease (GERD). - N/A
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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 an patients with erosive gastro-esophageal reflux disease (GERD). - N/A |
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Date of first enrolment:
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01/12/2005 |
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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: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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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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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Male or female (non-child bearing potential) subject aged 18 to 70 years inclusive.
2. A previous diagnosis of gastro-esophageal reflux disease by positive upper GI endoscopy (Los Angeles grade A, B or C)9 within 5 years of screening.
3. Active GERD as defined by a positive 24-hour pHmetry test at baseline. Positive is defined as having an esophageal pH of < 4 for > 5 % of the time.
4. Body Mass Index (BMI) of approximately 18 to 32 kg/m2; and a total body weight within the range of 40 to 120 kg.
5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
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:
1. Subjects with a history of significant cardiovascular disease, e.g. ischemic heart disease, arrhythmias, QT prolongation, MI or stroke.
2. Subjects with a resting BP greater than 170/110 mmHg or less than 90/50 mmHg.
3. Subjects with a significant history of symptomatic postural hypotension or greater than a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure on standing at screening.
4. Subjects with previously diagnosed renal impairment. Subjects with creatinine values > 2x ULN and/or with a significant change to their normal values should be excluded.
5. Subjects with previously diagnosed hepatic impairment. Subjects with liver function tests > 2 x ULN and/or with a significant change to their normal values should be excluded.
6. Subjects with a history of esophageal strictures.
7. Subjects with a history of esophageal dysmotility syndromes such as achalasia or nutcracker esophagus.
8. Subjects with upper GI endoscopic scoring of Los Angeles grade D.
9. Subjects with symptoms of dysphagia.
10. Subjects currently being treated for active gastric or duodenal ulceration.
11. Subjects diagnosed with Barrett’s esophagus.
12. Subjects that have had a surgical treatment for GERD, e.g. fundoplication.
13. Subjects with any condition possibly affecting drug absorption (e.g. gastrectomy).
14. Subjects with a history or presence of esophageal or gastric neoplasms.
15. Subjects with a history of allergic disease (including drug allergies, but not untreated or treated seasonal allergies or mild asthma/eczema).
16. Subjects with a positive urine drug screen.
17. Subjects who have a history of regular alcohol consumption exceeding 21 drinks per week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of screening.
18. Subjects who have received treatment with an investigational drug within 4 months preceding the first dose of study medication.
19. Subjects who are unable or unwilling to withdraw from acid suppressing (e.g. proton pump inhibitors or H2 receptor antagonists), gastro-prokinetic or other drugs for the treatment of GERD for the duration of the study (including the 7 days prior to the baseline pHmetry test).
20. Subjects who are taking or have taken within 14 days of dosing any drugs that are known to be potent CYP3A4 inhibitors (e.g. ketoconazole, erythromycin, clarythromycin).
21. Subjects taking b-blocker agents within 28 days of first dose.
22. Subjects with a screening 12-lead ECG demonstrating any of the following: heart rate >120 bpm, QRS duration >120 msec, QTc interval >430 msec, PR interval >210 msec, any clinically significant rhythm abnormality, any evidence of myocardial ischemia or injury.
23. Subjects that have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
24. Subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia.
25. Subjects with any clinically significant laboratory abnormalities that may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
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: 8.0
Level: LLT
Classification code 10017885
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Intervention(s)
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Product Name: N/A
Product Code: CJ-040,714
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: N/A
CAS Number: 847605-11-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: N/A
Product Code: CJ-040,714
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: CJ-040,714
CAS Number: 847605-11-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated 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): All endpoints should be calculated for upright, supine, daytime and night-time reflux events, however the primary focus of interest will be total (defined by upright + supine) events.
Primary
· Fraction of time esophageal pH < 4
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Secondary ID(s)
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A7421007
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N/A
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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