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    Summary
    EudraCT Number:2008-007420-26
    Sponsor's Protocol Code Number:D9127C00002
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-07-14
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-007420-26
    A.3Full title of the trial
    A phase IIa, double-blind, randomized, 2-way cross-over study to evaluate the effect of a single dose of AZD1386 95 mg compared to placebo in a multimodal experimental pain model on esophageal sensitivity in GERD patients with a partial response to PPI treatment
    A.3.2Name or abbreviated title of the trial where available
    na
    A.4.1Sponsor's protocol code numberD9127C00002
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numberna
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 No
    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 nameAZD1386 Oral Solution 2.5 mg/ml
    D.3.2Product code AZD1386 Oral Solution 2.5 mg/ml
    D.3.4Pharmaceutical form Oral solution
    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 n.a
    D.3.9.2Current sponsor codeAZD1386
    D.3.9.3Other descriptive namen.a
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 No
    D.3.11.8Extractive medicinal product No
    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 placeboOral solution
    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
    Gastroesophageal Reflux Disease (GERD) is the intended indication
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10017924
    E.1.2Term Gastroesophageal reflux
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare a single dose of AZD1386 to placebo on esophageal sensitivity to thermal stimuli 1.5 hours post dose in GERD patients who are partial responders to PPI.
    E.2.2Secondary objectives of the trial
    · To compare a single dose of AZD1386 to placebo on esophageal sensitivity to thermal stimuli 0.5 and 2.5 hours post dose in GERD patients who are partial responders to PPI
    · To compare a single dose of AZD1386 to placebo on esophageal sensitivity to mechanical stimuli 0.5, 1.5 and 2.5 hours post dose in GERD patients who are partial responders to PPI
    · To compare a single dose of AZD1386 to placebo on esophageal sensitivity to electrical stimuli 0.5, 1.5 and 2.5 hours post dose in GERD patients who are partial responders to PPI
    · To assess the safety and tolerability of a single dose of AZD1386
    · To assess the pharmacokinetic properties of AZD1386
    · To assess somatic pain by thermal and pressure stimuli on the arm(s) as control experiments to esophageal (visceral) pain experiments
    · To collect and store DNA for future exploratory research into genes that may influence response i.e. PK-profile, safety, tolerability and efficacy of AZD1386 treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed informed consent before any study specific procedures
    2. Able to read and write
    3. Able and willing to comply with all study requirements
    4. Have reported in the modified RDQ-RI screening instrument (7-day recall) a burning feeling behind the breastbone with a frequency of at least 3 days or more over the past 7 days and with at least moderate intensity and/or unpleasant movement of material upwards from the stomach with a frequency of at least 3 days or more over the past 7 days and with at least moderate intensity.
    5. Male or female, age 18-70 years, inclusive. Females must not be of childbearing potential or must have used one of the following highly effective contraceptive methods for the last 3 months, in addition, they must have two negative pregnancy tests at V1 and V3 with at least 14 days between the visits.
    No childbearing potential criteria
    - Post-menopausal females (either of);
    - Females >50 years and have been amenorrheic for 12 months or more and have not used exogenous hormonal treatment
    - Females >50 years and have been amenorrheic for 12 months or more, following cessation of all exogenous hormonal treatments
    - Females >57 years regardless of whether they are on Hormonal Replacement Therapy (HRT)
    - Permanent sterilisation by hysterectomy and/or bilateral oophorectomy
    Women of childbearing potential must use one of the following highly effective contraceptive methods
    - True abstinence (ie, not just stopping intercourse for the duration of the trial).
    - Vasectomised sexual partner (with appropriate post-vasectomy documentation of the absence of sperm in ejaculate.
    - Implanon® (Etonogestrel slow-release subcutaneous implant)
    - Female sterilisation by bilateral tubal ligation/occlusion
    - IUD/IUS provided coils are copper-banded
    - Mirena® - levonorgestrel containing IUS
    - Depo Provera® injections (medroxyprogesterone)
    - Normal and low dose combined oral contraceptive (COC)—only if used in TriCycle regime. This means instead of taking a single 3-week course of COC pills followed by one week off COC, the patient takes 3 or 4 courses together (i.e., 9-12 weeks of daily COC) with, between each prolonged cycle, a shortened 4-day pill free interval (PFI) rather than the usual 7-day PFI. Note: the less commonly used Triphasic pills, which have different strength pills in the same pack, are not considered highly effective and are therefore excluded from this instruction.
    - Evra Patch: norelgestromin/ethinyl estradiol transdermal system—only if used in above. Tricycle regime with 4-day patch-free intervals after each long cycle
    - Nuvaring (intravaginal device containing ethinyloestradiol and etonogestrel (3-ketodesogestrel)—only if used in above Tricycle regime with 4-day ring-free intervals after each long cycle
    - Cerazette™ (desogestrel-releasing progestogen-only pill with established failure rate of <1 per 100 women in first year).
    6. BMI 18.5 – 35.0, inclusive
    7. Have at least 6 months history of GERD symptoms (need not to be consecutive) and one of the following:
    (a) A gastroscopy, not demonstrating an erosive condition or any other serious abnormality, as judged by the investigator, within the last 2 years and with nosignificant deterioration in symptoms since gastroscopy.
    (b) A gastroscopy performed as a screening procedure, if no gastroscopy has been done within the last 2 years, not demonstrating an erosive condition or any other serious abnormality, as judged by the investigator.
    8. Continuously treated with optimised unchanged PPI treatment with doses within the approved label for any GERD indication during the last 4 weeks before enrolment. (An optimised PPI treatment is a treatment that according to the investigators judgment cannot be further improved by changing brand or dosing of the PPI).
    9. Have a PPI prescription with refills that covers the study period.
    In addition, following criterion must be fulfilled for inclusion into the optional genetic research:
    10. Provision of signed, written and dated informed consent for genetic research
    If a patient declines to participate in the genetic component of the study, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.
    E.4Principal exclusion criteria
    1. Patients that have not experienced any GERD symptoms improvement at all after PPI treatment (non-responders)
    2. PPI treatment with doses outside the approved label for GERD and GERD related indications. Note: Twice daily (bid) dosing is not allowed.
    3. Unstable or clinically significant disorders including cardiovascular, respiratory, renal, hepatic, metabolic, psychiatric, other gastrointestinal and esophageal disorders besides GERD. Patients with uncomplicated, well-controlled hypertension (SBP £140 and DBP £90) could be included.
    - Clinical significant is defined as disorders that could compromise patients’ safety or interfere with the evaluation of the study as judged by the investigator.
    4. Concomitant use of strong and moderate CYP3A4 enzyme inhibitors, such as ketoconazole, itraconazole, clarithromycin, nefazodone, erythromycin, fluconazole, aprepitant, diltiazem, verapamil, grapefruit juice, HIV protease inhibitors.
    5. History of malignancy, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
    6. Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes. This includes subjects with any of the following:
    - Clinically significant PR (PQ) interval prolongation
    - Intermittent second or third degree AV block
    - Incomplete, full or intermittent bundle branch block (QRS < 110ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
    - Abnormal T wave morphology, particularly in the protocol defined primary lead
    - Prolonged QTcF >450 msec or shortened QTcF <350 msec
    - Family history of long QT syndrome
    7. ASAT or ALAT > 2 times ULN or bilirubin 1.5 times ULN at pre-entry visit
    8. Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
    9. Prior surgery of the upper GI tract (open, endoscopic and laparoscopic surgery on the esophagus, the stomach and the duodenum with the exception of oversewing or endoscopic treatment of bleeding ulcer)
    10. History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity
    11. Need for concomitant medication with the following:
    Drugs that may interfere with the pharmacodynamic effect of the Investigational Product
    Drugs that may influence gastrointestinal symptoms.
    12. Risk factors for ventricular fibrillation eg family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) among first-degree relatives
    13. History of drug addiction, drug abuse (including cannabinoids) or alcohol abuse and/or positive drug screen or other circumstances which in the investigators judgment may compromise the patient’s ability to comply with the study requirements
    15. Excessive intake of caffeine containing drinks eg, coffee, tea, caffeine containing energy drinks or Coke (more than 5 cups of coffee or equivalent per day)
    16. Pregnant or breast feeding females
    17. Any other condition which in the opinion of the investigator would render the patient unsuitable for inclusion in the study
    18. Plasma or blood donation within two weeks prior to enrollment or any blood loss equivalent to the amount of a blood donation during the 3 months prior to enrollment
    19. Involvement in the planning or conduct of the study (applies to both AZ staff and staff at the study site)
    20. Administration of any investigational product within 8 weeks prior to administration of the first dose of study drug
    21. Previous enrolment or randomisation of treatment in the present study or previous exposure to AZD1386
    22. Positive HIV (human immunodeficiency virus) or hepatitis B or C test
    In addition, the following criterion is regarded as a criterion for exclusion from the genetic research;
    23. Previous bone marrow transplant
    24. Whole blood transfusion within 120 days prior to the date of blood sampling for genetic research
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to compare a single dose of AZD1386 to placebo on esophageal sensitivity to thermal stimuli 1.5 hours post dose in GERD patients who are partial responders to PPI.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Post-menopausal and Permanently sterilised females
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 Decision2009-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-01-12
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