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    Summary
    EudraCT Number:2007-001487-67
    Sponsor's Protocol Code Number:A8311003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-10
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2007-001487-67
    A.3Full title of the trial
    A PARALLEL-GROUP, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER DOSE RESPONSE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF- 00885706, A 5-HT4 RECEPTOR PARTIAL AGONIST, AS ADD-ON THERAPY TO ESOMEPRAZOLE FOR THE RELIEF OF SYMPTOMS IN SUBJECTS WITH GASTRO-ESOPHAGEAL REFLUX DISEASE (GERD) WHO HAVE A POOR RESPONSE TO PROTON PUMP INHIBITOR (PPI) TREATMENT
    A.4.1Sponsor's protocol code numberA8311003
    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, Ramsgate Road, Sandwich, CT13 9NJ Kent, UK
    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 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.3.2Product code PF-00885706
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codePF-00885706
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.3.2Product code PF-00885706
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codePF-00885706
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.3.2Product code PF-00885706
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codePF-00885706
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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.3.2Product code PF-00885706
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codePF-00885706
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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*
    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 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018203
    E.1.2Term GERD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To understand the dose-response characteristics of PF-00885706 for efficacy in terms of symptomatic relief when used as add-on treatment to Esomeprazole 20mg (standard PPI treatment), in subjects with GERD who have inadequate relief with PPIs.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety of PF-00885706 in subjects with GERD who are poor responders to PPI treatment.
    • To evaluate the population pharmacokinetics (POPPK) for PF-00885706 in a population of subjects with GERD in order to support the development of a PKPD model.
    • To validate a modified patient reported outcome (PRO) instrument [modified version of the Patient Assessment of Gastro-Intestinal SYMptoms {PAGI-SYM} instrument] in electronic format.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 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 study.
    2. Subjects with a diagnosis of GERD who fulfill the following criteria
    • who have symptoms for at least six months prior to enrolment
    • who are currently prescribed daily treatment with a PPI and have been on such treatment for at least 3 months
    • whose symptoms are persistent 1, troublesome and that include heartburn and/or regurgitation as their predominant symptoms despite treatment with a PPI
    • who are seeking relief of persistent symptoms
    Persistent symptoms: Minimum of 4 days (in a week) with at least mild symptoms (ie symptom does not last long and is easily tolerated) or minimum of 2 days with moderate (ie symptom causes discomfort and interrupts usual activities including sleep) to severe symptoms (ie symptom causes great interference with usual activities [including sleep] and may be incapacitating.
    3. Male or female subject aged 18 to 65 years inclusive.
    4. All female subjects must fulfill adequate contraception criteria
    A negative serum or urine pregnancy test within 72 hours prior to start of study medication for Women of Child Bearing Potential (WOCBP*). WOCBP include any
    female who has experienced menarche and who has not undergone successful surgical sterilization or is not post-menopausal**. Even women who are using oral, implanted or injectable contraceptive hormones or mechanical products (intrauterine devices; barrier methods) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (eg, vasectomy), should be considered to be of child bearing 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 to 60 years of age must be amenorrheic for at least 2 years PLUS have a serum FSH level within the laboratory’s reference range for postmenopausal women.
    • Females who are permanently sterilized (e.g. hysterectomy, bilateral oophorectomy and tubal ligation).
    All other female subjects will be considered to be of childbearing potential and willing to utilize an acceptable form of contraception*** from screening to at least a month after the study.
    *** Acceptable contraceptive method for female subjects of childbearing potential
    include one of the following: Female subjects who wish to use nonhormonal contraception must have done so for at least 14 days prior to the first dose of study medication.
    • Combined oral contraceptive pill
    • Hormonal methods of contraception (including injectable [e.g Depo-Provera, Lunelle], implants [eg Norplant]) at least 14 days prior to the first dose of study medication;
    • Placement of a copper-containing intrauterine device (IUD);
    • Male partner who has had a vasectomy for at least 4 months
    5. Body Mass Index (BMI) of 18 to 40 kg/m2
    6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    1.Subjects not able or unwilling to provide informed consent and or to follow study procedures or considered to be non compliant according to the investigator
    2.Subjects with any of the following diseases/conditions which, in the opinion of the investigator, may be the cause of or may contribute significantly to symptoms associated with GERD:
    a. Zollinger-Ellison syndrome
    b. Primary esophageal motility disorder, ie achalasia, scleroderma, primary esophageal spasm or nutcracker esophagus.
    c. Esophageal disorders such as strictures and Barrett’s esophagus
    d. Surgical or endoscopic treatment for GERD, eg fundoplication, gastrectomy, history or presence of esophageal or gastric neoplasms
    e. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer
    f. Active gastric or duodenal ulcers.
    g. Malabsorption or Inflammatory Bowel Disease
    h. Irritable Bowel Syndrome
    i. Hiatus hernia
    3.Subjects diagnosed with erosive esophagitis (subjects must have had an endoscopy within the last 5 years to verify absence) or alarm symptoms such as dysphagia (difficulty swallowing); odynophagia (painful swallowing); gastrointestinal bleeding or anemia; weight loss; and chest pain.
    4.If female; pregnant, lactating or positive serum or urine pregnancy tests.
    5.Subjects presenting with any of the following will not be included in the study:
    • Cardiovascular
    a. Subjects with a history of cardiovascular disease, eg ischemic heart disease, arrhythmias, QT prolongation (QTcF > 450 msec), myocardial infarction or stroke
    b. Subjects with uncontrolled hypertension (BP > 140/90 mm of Hg), or a history of symptomatic hypotension at screening
    c. 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
    d. Subjects with a screening 12-lead ECG demonstrating any clinically significant abnormality, including QT prolongation (QTcF > 450 msec)
    e. Subjects on beta adrenoceptor blocking drugs
    • Renal impairment (creatinine > 1.5 x ULN and/or estimated creatinine clearance ≤50 mL/min using Cockcroft-Gault equation).
    • Alanine aminotransferase (ALT) ≥2 times the upper limit of normal (ULN) at screening (Visit 1) as defined by the central laboratory;
    • Subjects with a history of malignancy who have not been in remission for at least 5 years at the time of the baseline visit.
    Note for clarification: Subjects with basal and squamous cell carcinomas are eligible for entry within the 5 year period provided they have been disease-free for 12 months at the time of entry, and they are followed up regularly by a dermatologist
    • Uncontrolled diabetes mellitus (HbA1c > 7). Stable diabetes controlled by diet, oral agents or insulin is acceptable
    • History of ethanol abuse, substance abuse, or social situations that may affect adherence to the study protocol
    • Subjects with a positive Hepatitis B, Hepatitis C or HIV test.
    6.Subjects who have received any investigational drug or device within 30 days of screening, or who is scheduled to receive another investigational drug or device in the course of the study.
    7.Subjects who are unable or unwilling to withdraw from prescribed proton pump inhibitors and replace with standard study PPI treatment (Esomeprazole 20mg).
    8.Subjects who are unable or unwilling to stop gastro-prokinetic or other drugs for the treatment of GERD for the duration of the study (eg H2RAs, metoclopramide)
    9.Subjects who are unable to tolerate or are allergic to
    •Gaviscon™ (sodium alginate) or its excipients (due to its aspartame content this product should not be given to patients with phenylketonuria).
    •Esomeprazole treatment (substituted benzimidazoles or any other constituents of the formulation) or their excipients (which may contain sucrose). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine).
    10.Subjects who are taking, or have taken within 14 days of Visit 2 (start of run-in), any drugs that are known to be potent CYP3A4 inhibitors (eg ketoconazole, erythromycin, clarythromycin); potent CYP3A4 inducers (eg rifampicin, phenobarbital) and potent CYP2C19 inducers (eg carbamazepine) or inhibitors (eg fluoxetine)
    11.Subjects with factors that may interfere with efficacy assessment (include but not restricted to other illness that affect quality of life or inability to complete the electronic diary).
    12.Subjects that have made a blood donation of approximately 500 mL (1 pint) within 30 days prior to screening.
    13.Subjects with any clinically significant laboratory abnormalities that may increase the risk associated with study participation or may interfere with the interpretation of the study results.
    E.5 End points
    E.5.1Primary end point(s)
    Complete resolution of heartburn and regurgitation [i.e. no more than one day with either mild heartburn or regurgitation over seven days prior to the assessment time point (Visit 6 and Visit 8)]
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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 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) No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 450
    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 Decision2008-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-03-26
    P. End of Trial
    P.End of Trial StatusCompleted
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