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    Summary
    EudraCT Number:2009-012935-13
    Sponsor's Protocol Code Number:D9120C00019
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-09-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-012935-13
    A.3Full title of the trial
    A randomized, double-blind, placebo controlled, multi-centre phase IIb dose finding study to assess the effect on GERD symptoms, safety and tolerability during four weeks treatment with AZD3355 in doses 60 mg, 120 mg, 180 mg and 240 mg bid as add-on treatment to a PPI in patients with GERD that are partial responders to PPI treatment
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberD9120C00019
    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 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 nameAZD3355 modified release capsules MR 1h, 30 mg
    D.3.2Product code AZD3355 modified release capsules MR 1h, 30 mg
    D.3.4Pharmaceutical form Modified-release capsule, hard
    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 344413-67-8
    D.3.9.2Current sponsor codeAZD3355
    D.3.9.3Other descriptive namen.a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.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 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 nameAZD3355 modified release capsules MR 1h, 60 mg
    D.3.2Product code AZD3355 modified release capsules MR 1h, 60 mg
    D.3.4Pharmaceutical form Modified-release capsule, hard
    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 344413-67-8
    D.3.9.2Current sponsor codeAZD3355
    D.3.9.3Other descriptive namen.a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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.IMP: 3
    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 nameAZD3355 modified release capsules MR 1h, 120 mg
    D.3.2Product code AZD3355 modified release capsules MR 1h, 120 mg
    D.3.4Pharmaceutical form Modified-release capsule, hard
    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 344413-67-8
    D.3.9.2Current sponsor codeAZD3355
    D.3.9.3Other descriptive namen.a
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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 placeboCapsule, hard
    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 12.0
    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 is to evaluate the effect on GERD symptoms of four doses of AZD3355 (60 mg, 120 mg, 180 mg and 240 mg bid) compared to placebo, as add-on treatment to a PPI by using the responder definition; ie, at least 3 more days of not more than mild GERD symptoms on average per week during the whole treatment period compared to baseline, based on the Overall symptoms domain in the Reflux Symptom Questionnaire electronic Diary (RESQ-eD).
    E.2.2Secondary objectives of the trial
    *To evaluate the effect on GERD symptoms of four doses of AZD3355 compared to placebo, as add-on treatment to a PPI by using an alternative responder definition, the effect on GERD symptoms of four doses of AZD3355 compared to placebo, as add-on treatment to a PPI by analysing the change in the proportion of days of not more than mild GERD symptoms compared to baseline, based on the Overall symptoms domain and for each separate domain in the RESQ-eD and the dose-response curve with respect to the responder definition and the change in the proportion of days of not more than mild GERD symptoms compared to baseline. *To assess basic measurement properties of the RESQ-eD and the pharmacokinetics of AZD3355 by population PK analyses. *To study the relationship between systemic exposure and response and the prevalence of mucosal breaks in the target population. *To describe the endoscopic findings after the study treatment period, in patients with baseline endoscopy showing mucosal breaks.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Male or female. Females of childbearing potential must be using a highly effective contraceptive method for at least the previous 3 months, see Section 5.1.1
    3. Age 18-70 years, inclusive
    4. Body Mass Index (BMI) 18.5 – 35.0 kg/m2, inclusive
    5. Have at least 6 months history of GERD symptoms (need not to be consecutive)
    6. Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy with doses according to the country label, or regional where applicable, for any GERD indication. Patients with endoscopy verified reflux esophagitis (Los Angeles classification grade A-D) within the last 8 weeks must have completed the prescribed 8 weeks treatment with a PPI. An optimized PPI treatment is a treatment which according to the investigator judgment can not be further improved by changing brand or dosing of the PPI.
    7. Have a PPI prescription with refills that cover the whole study period or instructions by a physician to use an over the counter (OTC) PPI in accordance with the labelling of their prescription counter-part
    8. Able to read and write in the local language and use the e-diary device
    9. To be eligible for the screening phase the patients must have reported in the RESQ-7 using 7 days recall of symptoms, a minimum of 3 days and a rating of at least moderate intensity on at least one of the following items; a burning feeling behind the breastbone or unpleasant movement of material upwards from the stomach. (An algorithm which is programmed in the e-diary device, will determine eligibility automatically).
    10. To be eligible for randomization the patients must have recorded in the RESQ-eD on the last 7 days before randomization, a minimum of 3 days with a symptom intensity of at least moderate on either item, or any combination of both items (eg 1 day on one item and 2 days on the other); a burning feeling behind the breastbone or unpleasant movement of material upwards from the stomach. (An algorithm, which is programmed in the e-diary device, based on the e-diary recordings, will determine whether the patient fulfils the criteria).
    11. An upper gastrointestinal endoscopy is required before randomization provided that:
    - no endoscopy has been performed within the past 24 months
    - the most recent endoscopy within 24 months demonstrated mucosal breaks in the esophagus
    - no documented endoscopy report from the most recent endoscopy within 24 months is available to the investigator.
    If the most recent available documented report from an upper endoscopy within the past 24 months confirms the absence of mucosal breaks then the patient does not need to undergo an endoscopy during this study.
    E.4Principal exclusion criteria
    1. Patients that have not experienced any GERD symptom improvement at all during PPI treatment
    2. PPI treatment with doses not according to the country label, or regional where applicable, for any GERD indication. Note: bid dosing is not allowed
    3. Working night-shift during the period of the study
    4. Unstable or clinically significant cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric, other clinical disorders, or gastrointestinal and esophageal disorders besides GERD. Clinically significant is defined as disorders that could compromise patients’ safety or interfere with the evaluation of the study as judged by the investigator. Patients with uncomplicated, well-controlled hypertension (SBP≤160 and DBP≤ 90) and patients with uncomplicated, well-controlled Diabetes Mellitus, as judged by the investigator, can be included
    5. Current neurological disorders including nerve compression syndromes. Patients with well controlled migraine and other headache disorders can be included
    6. History of clinically significant orthostatic reaction or syncope. Clinically significant orthostatic reaction at visit 1 or pre-dose at visit 2
    7. Supine systolic blood pressure below 110 mm Hg at visit 1 and pre-dose visit 2
    8. History of a heart disease (including ischemic heart disease, congestive heart failure, cardiac arrhythmias, congenital long QT syndrome), or current signs or symptoms of any heart disease, or patients with clinically significant ECG abnormalities or QTcF >450 ms as determined by the investigator (see section 6.4.7)
    9. History of or current malignant disease (radically treated basal cell cancer is allowed)
    10. History of clinically significant electrolyte imbalances
    11. A history of severe allergic or hypersensitivity reactions (such as Stevens Johnson syndrome, anaphylactic shock, angioedema-urticaria)
    12. Need for concomitant medication with:
    · Drugs or any compound that may interfere with the pharmacodynamic effect of investigational product (eg, Baclofen, pure GABA, supplements containing GABA)
    · Drugs that by their mode of actions may alter gastrointestinal (GI) symptoms, with exception of the PPI used in the study and antacids, (eg, H2 receptor antagonists, sucralfate, alginates, tegaserod, domperidone, metoclopramide, erythromycin), drugs with significant anticholinergic effect (eg, anticholinergics used in gastro-intestinal disorders; anticholinergics used for Parkinson’s disease; anticholinergics used for urine bladder disorders; tricyclic antidepressants)
    · Drugs that may cause mucosal damage in the GI tract
    - Non-steroid anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors, more than 2 days/week
    - Acetylsalicylic acid (ASA) >162 mg/day
    - Bisphosphonates
    - Antineoplastic drugs
    · Drugs that may prolong the QT interval. Common examples of such drugs are listed in Appendix E. This list should not be considered comprehensive therefore investigators need to use their judgement when reviewing the medication list from individual patients and restrict patients who must stay on drugs that may increase the QT interval
    · Drugs that have a narrow therapeutic window (eg, warfarin, digoxin, phenytoin, carbamazepine)
    13. 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 a bleeding ulcer)
    14. History of drug addiction, drug abuse (including cannabinoids) or alcohol abuse or other circumstances which in the investigators judgement may compromise the patient’s ability to comply with the study requirements
    15. Pregnant or breastfeeding females
    16. Any other condition which in the opinion of the investigator would render the patient unsuitable for inclusion in the study
    17. Blood donation within 8 weeks prior to the first dose of the investigational product
    18. Involvement in the planning and/or conduct of the study (applies to all AstraZeneca/ AstraZeneca representative/study site personnel)
    19. Previous enrolment or randomization in the present study or in another study with AZD3355
    20. Participation in another clinical study, with administration of any investigational product during the last 2 months prior to enrolment
    21. The following laboratory exclusion criteria based on laboratory samples from visit 1 assessed at visit 2:
    - S-creatinine >1.2 x ULN
    - S-AST or ALT > 2 x ULN
    - S-bilirubin > 1.5 x ULN
    - S-potassium below the lower reference range
    - S-magnesium below the lower reference range
    - Other clinically significant electrolyte imbalances as judged by the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy variable: The binary variable (yes/no) indicating a patient fulfilling the responder definition: at least 3 more days of not more than mild GERD symptoms on average per week during the whole treatment period compared to baseline based on the Overall symptoms domain in the RESQ-eD.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Yes
    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
    Last Visit of the Last Subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 state143
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 650
    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)
    n.a.
    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 Decision2009-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-07-08
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