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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   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:2008-005604-54
    Sponsor's Protocol Code Number:NXL104/2002
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-13
    Trial 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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2008-005604-54
    A.3Full title of the trial
    A prospective, multicentre, double-blind, randomized, comparative study to estimate the safety, tolerability and efficacy of NXL104/ceftazidime plus metronidazole vs. meropenem in the treatment of complicated intra-abdominal infections (cIAI) in hospitalized adults
    A.3.2Name or abbreviated title of the trial where available
    NXL104 Study
    A.4.1Sponsor's protocol code numberNXL104/2002
    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 SponsorNovexel, S.A.
    B.1.3.4CountryFrance
    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 nameNXL104
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet attributed
    D.3.9.2Current sponsor codeNXL104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    D.2.1.1.1Trade name Ceftazidime 2.0 g powder for solution for injection/infusion
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCeftazidime pentahydrate
    D.3.9.1CAS number 72558-82-8
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.3296
    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 Yes
    D.2.1.1.1Trade name Metronidazole 500 mg/100 ml Intravenous Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Healthcare Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMetronidazole
    D.3.9.1CAS number 443-48-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Meronem IV
    D.2.1.1.2Name of the Marketing Authorisation holderAstaZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeropenem trihydrate
    D.3.9.1CAS number 119478-56-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1140
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated intra-abdominal infections (cIAI) in hospitalised adults
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10056570
    E.1.2Term Intra-abdominal infection
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the efficacy of NXL104/ceftazidime plus metronidazole with respect to the clinical response in baseline microbiologically evaluable patients with cIAI at the Test of Cure (TOC) visit, 2 weeks post-treatment, compared to meropenem.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability profile of NXL104/ceftazidime plus metronidazole in the treatment of cIAI in adults.
    2. To estimate the efficacy of NXL104/ceftazidime plus metronidazole with respect to the clinical response in baseline microbiologically evaluable patients with cIAI at the end of IV therapy and at the late follow-up visit at 4 to 6 weeks post-treatment compared to meropenem.
    3. To estimate the clinical response of NXL104/ceftazidime plus metronidazole at the end of IV therapy, at the Test of Cure visit, and at the late follow up visit, 4 to 6 weeks post therapy compared to meropenem.
    4. To estimate the microbiological response of NXL104/ceftazidime plus metronidazole in with cIAI at the end of IV therapy, at the Test of Cure visit, and at the late follow-up 4 to 6weeks post-therapy, compared to meropenem.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 to 90 years of age
    Women are authorized to participate in this clinical study if they meet the following criteria:
    � Has been surgically sterilized or post menopausal for at least one year
    OR
    � Is of childbearing potential, and all of the following conditions are met:
    - had normal menstrual periods for the 3 months prior to study entry, and
    - has a negative serum pregnancy test (serum β-hCG) within 1 day prior to enrollment.
    - must be willing to practice double barrier methods of birth control (e.g., condoms or
    diaphragms together with spermicidal foam or gel) during treatment and for at least 28 days after dosing with study medication. Oral contraceptives should not be used as the sole method of birth control, because the effect of NXL104 on the efficacy of oral contraceptives has not yet been established.

    2. Intraoperative/postoperative enrollment
    Patients may be enrolled intraoperatively or postoperatively upon visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection. Surgical intervention includes open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery.
    Diagnoses considered eligible for this study are those in which there is evidence of intraperitoneal infection.

    The patient must have one of the following diagnoses:
    a. cholecystitis with gangrenous rupture or perforation or progression of the infection beyond the gallbladder wall
    b. diverticular disease with perforation or abscess
    c. appendiceal perforation or peri-appendiceal abscess
    d. acute gastric and duodenal perforations, only if operated on > 24 hours after perforation occurs
    e. traumatic perforation of the intestines, only if operated on > 12 hours after perforation occurs
    f. secondary peritonitis (but not spontaneous bacterial peritonitis associated with cirrhosis and chronic
    ascites)
    g. intra-abdominal abscess (including of liver and spleen provided that there is extension beyond the organ with evidence of intraperitoneal involvement)

    AND
    Specimens from the surgical intervention are sent for culture and susceptibility testing
    AND
    Infection is caused or presumed to be caused by mircroorganisms susceptible to the intravenous study medications (ceftazidime/NXL104 plus metronidazole or meropenem)
    Note: 1) infections limited to the hollow viscus, such as simple cholecystitis and simple appendicitis, are not
    eligible. Ischemic bowel disease without perforation is not eligible. Acute suppurative cholangitis and acute necrotizing pancreatitis are not eligible. 2) Postoperative (or intraoperative) enrollment of patients is encouraged. If, however, preoperative data are available that strongly suggest an appropriate diagnosis for entry
    (e.g., rupture of intraperitoneal abscess on CT or MRI), then these patients may be enrolled preoperatively.

    3. For Preoperative Enrollment
    The following clinical criteria must be met, and the patient’s infection must be confirmed by a surgical intervention within 24 hours of entry:
    a. Evidence of systemic inflammatory response, with at least one of the following:
    1) Fever (temperature > 37.8°C; > 38°C tympanic; > 38.3°C rectal; or hypothermia with a core body temperature < 35°C
    2) Elevated WBC (> 10,500/mm3)
    3) Drop in blood pressure (however, systolic BP must be > 90 mm Hg without pressor support)
    4) Increased pulse (HR > 90) and respiratory rates (> 20)
    5) Hypoxemia
    6) Altered mental status
    AND
    b. Physical findings consistent with Intra-abdominal infection, such as:
    1) Abdominal pain and/or tenderness, with or without rebound
    2) Localized or diffuse abdominal wall rigidity
    3) Mass
    4) Ileus
    AND
    c. Supportive radiologic imaging findings of intra-abdominal infection such as perforated intraperitoneal abscess detected on CT scan, MRI, or ultrasound
    AND
    d. requirement for surgical intervention, including open laparotomy, percutaneous drainage of an abscess, or laparoscopic surgery;
    AND
    e. Specimens from the surgical intervention are sent for culture and susceptibility testing
    AND
    f. Infection is caused or presumed to be caused by mircroorganisms susceptible to the intravenous study
    medications (ceftazidime/NXL104 plus metronidazole or meropenem)
    E.4Principal exclusion criteria
    1. Patient diagnosed with traumatic bowel perforation with surgery within 12 hours; perforation of gastroduodenal ulcers with surgery within 24 hours. Other intra-abdominal processes in which the primary etiology is not likely to be infectious.
    2. Patient with abdominal wall abscess or small bowel obstruction without perforation or ischemic bowel without perforation.
    3. Patient with simple cholecystitis; or gangrenous cholecystitis without rupture; or simple appendicitis; or acute suppurative cholangitis; or infected necrotizing pancreatitis or pancreatic abscess
    4. Patient whose surgery will include staged abdominal repair, or “open abdomen” technique, or marsupialization.
    5. Patient known at study entry to have intra-abdominal infections that are caused by pathogens resistant to the study antimicrobial agents.
    6. Patient with evidence of sepsis with shock not responding to intravenous fluid challenge or anticipated to require the administration of vasopressors for > 12 hours.
    7. Patient with perinephric infections.
    8. Female patient with infection of the genital tract.
    9. Patient with indwelling peritoneal catheter.
    10. Patients with suspected amebic liver abscess.
    11. Patient with history of serious allergy, hypersensitivity (e.g., anaphylaxis), or any serious reaction to carbapenem or cephalosporin antibiotics or other beta lactam antibiotics.
    12. Patient with APACHE II score > 25 (see appendix 6).
    13. Patient who is considered unlikely to survive the 6- to 8-week study period.
    14. Patient who is unlikely to respond to 5 to 14 days of antibiotic therapy.
    15. Patient with rapidly progressive or terminal illness, including acute hepatic failure or respiratory failure.
    15. Male patient who is not willing to abstain from sexual intercourse with a fertile woman without use of a condom/spermicide while taking the study drug and for at least 90 days after treatment with study drug.
    16. Female patient who is pregnant or breastfeeding, or fertile woman not practicing adequate methods of contraception (as defined in inclusion criteria); or planning to become pregnant within 1 month of the study.
    17. Patient who received systemic antibacterial agents within the 72-hour period prior to study entry, unless either of the following pertains:
    • Patient with new infection (not considered a treatment failure) may receive no more than 24 hours of total antibiotic therapy [preoperatively (prophylaxis) and/or postoperatively];
    • Patient is considered to have failed the previous treatment regimen. In this case, preoperative treatment of any duration with nonstudy systemic antimicrobial therapy for peritonitis or abscess is permitted provided that;
    a) the treatment regimen has been administered for at least 72 hours and is thought to have been inadequate
    b) operative intervention that is just completed or is intended no more than 24 hours after study entry
    c) findings of infection were documented at surgery
    d) specimens for bacterial cultures and susceptibility testing are taken at operative intervention
    e) no further nonstudy antibacterials are administered after enrollment
    18. Patient who needs effective concomitant systemic antibacterials (other than vancomycin for documented Methicillin Resistant S. aureus or vancomycin, linezolid, or daptomycin for Enteroccal infections) in addition to those designated in the 2 study groups.
    19. Patient with concurrent infection that may interfere with the evaluation of response to the study antibiotic.
    20. Patient with a BMI > 45 kg/m2.
    21. Patient with Hematocrit <30% or Hemoglobin <10 g/dL.
    22. Patient with absolute neutrophil count (ANC) less than 1500/mm3. Patient with ANC as low as 1000/mm3 may be enrolled if this is directly related to the acute infection.
    23. Patient with Platelet count <100,000/mm3.
    24. Patient with Coagulation (prothrombin time [PT] and partial thromboplastin time [PTT] and/or INR) tests >1.5 times the upper limit of the range of normal values (ULN) used by the laboratory performing the test. Patients who are on anticoagulant therapy with values >1.5 times ULN may be enrolled provided these values
    are stable within the therapeutic range.
    25. Patient with an estimated creatinine clearance < 50mL/min by Cockcroft-Gault formula [45]. If a patient is dehydrated he/she should be rehydrated and creatinine re-measured before calculating creatinine clearance.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy assessment is the clinical response in the microbiologically evaluable population at the Test of Cure visit, 2 weeks post-therapy. The primary safety variable will be the incidence of adverse experiences.
    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 Yes
    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 No
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 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 years0
    E.8.9.1In the Member State concerned months12
    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 months12
    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) 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-04-13. Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 102
    F.4.2.2In the whole clinical trial 200
    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 Decision2009-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-12-19
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