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    Summary
    EudraCT Number:2007-001487-67
    Sponsor's Protocol Code Number:A8311003
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-08-28
    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 ConcernedFrance - ANSM
    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.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA8311003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Limited, Ramsgate Road, Sandwich, 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.3.1Product nameN/A
    D.3.2Product code PF-00885706
    D.3.4Pharmaceutical form Capsule*
    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 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.3.1Product nameN/A
    D.3.2Product code PF-00885706
    D.3.4Pharmaceutical form Capsule*
    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 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.3.1Product nameN/A
    D.3.2Product code PF-00885706
    D.3.4Pharmaceutical form Capsule*
    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 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.3.1Product nameN/A
    D.3.2Product code PF-00885706
    D.3.4Pharmaceutical form Capsule*
    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 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 in subjects 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 and in electronic formats.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Samples for Pfizer's exploratory research biobank
    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 on daily treatment with a PPI and have been on such treatment for at least 3 months
    • whose symptoms are persistent.
    * 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 (i.e. symptom does not last long and is easily tolerated) or minimum of 2 days with moderate (i.e. symptom causes discomfort and interrupts usual activities including sleep) to severe symptoms (i.e. 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 (e.g., 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 had a hysterectomy and/or bilateral oophorectomy.
    All other female subjects (including females with tubal ligations) will be considered to be of childbearing potential.
    Willingness to utilize an acceptable form of contraception***(e.g. hormonal contraception, intrauterine device, barrier method plus spermicide) for WOCBP 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.
    • Hormonal methods of contraception (including oral and transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs) at least 14 days prior to the first dose of study medication;
    • Placement of a copper-containing intrauterine device (IUD);
    • Condom with spermicidal foam/gel/film/cream/suppository;
    • 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
    a. Zollinger-Ellison syndrome
    b. Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary
    esophageal spasm or nutcracker esophagus.
    c. Esophageal disorders such as strictures, upper GI endoscopic scoring of Los
    Angeles grade D; dysphagia, Barrett’s esophagus,
    d. Surgical or endoscopic treatment for GERD
    e. History of esophageal, gastric or duodenal surgery, except for simple closure of
    an ulcer OR gastric or duodenal ulcers.
    f. Malabsorption or Inflammatory Bowel Disease
    g. Irritable Bowel Syndrome
    h. Large hiatus hernia
    3. Subjects diagnosed with erosive esophagitis or alarm symptoms such as dysphagia; odynophagia; 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, e.g. ischemic heart disease,
    arrhythmias, QT prolongation (> 450msec), myocardial infarction or stroke
    b. Subjects with uncontrolled hypertension (BP > 140/90 mm of Hg) or having
    symptomatic hypotension
    c. Subjects with a significant history of symptomatic postural hypotension or
    greater than a 20mmHg 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
    • Renal impairment
    • Alanine aminotransferase ≥2 times the upper limit of normal 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.
    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
    9. Subjects who are unable to tolerate or are allergic to
    a. Gaviscon™ or its excipients.
    b. Esomeprazole treatment or their excipients.
    10. Subjects who are taking, or have taken within 14 days of Visit 2, any
    drugs that are known to be potent CYP3A4 inhibitors; potent CYP3A4 inducers and potent CYP2C19 inducers or inhibitors
    11. Subjects with factors that may interfere with efficacy assessment.
    12. Subjects that have made a blood donation of approximately 500mL 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.
    14. Subjects with a disease or condition affecting their well-being to the extent that may adversely influence the reliability of the patient reported outcomes measured in this study, e.g. changes in the quality of life recorded by patients with a painful condition will depend on the changes in that condition, not the effect of the study treatment. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    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 No
    E.6.11Pharmacogenomic Yes
    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.8.5The 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 320
    F.4.2.2In the whole clinical trial 450
    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)
    As per protocol
    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 Decision2007-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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