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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-004155-35
    Sponsor's Protocol Code Number:A7421007
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-21
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-004155-35
    A.3Full title of the trial
    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).
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA7421007
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameN/A
    D.3.2Product code CJ-040,714
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 847605-11-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameN/A
    D.3.2Product code CJ-040,714
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCJ-040,714
    D.3.9.1CAS number 847605-11-2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastro-Esophageal Reflux Disease (GERD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.0
    E.1.2Level LLT
    E.1.2Classification code 10017885
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effect of CJ-040,714 on the fraction of time that esophageal pH is < 4.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal 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.
    E.4Principal 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.
    26. Subjects with a positive Hepatitis B, Hepatitis C or HIV test.
    27. Female subjects of childbearing potential. Female subjects of non-childbearing potential must meet at least one of the following criteria:
    · Postmenopausal females, defined as:
    · Females over the age of 60 years. Females who are 45-60 years of age must be amenorrheic for at least 2 years PLUS have a serum FSH level >30 IU/L.
    · Females who have had a hysterectomy and/or bilateral oophorectomy.
    All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
    28. Male subjects that are unable or unwilling to use a barrier method of contraception for the duration of the study.
    29. Subjects unwilling or unable to comply with the lifestyle guidelines.
    E.5 End points
    E.5.1Primary 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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    As per Protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A legally acceptable representative may provide consent.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 24
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None other than standard follow up visit.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2005-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-01-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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