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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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:2004-000370-31
    Sponsor's Protocol Code Number:NKT102260
    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:2005-12-02
    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 number2004-000370-31
    A.3Full title of the trial
    A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral Neurokinin-1 Receptor Antagonist, GW679769, When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of Post-operative Nausea and Vomiting (PONV) and Post-discharge Nausea and Vomiting (PDNV) in Female Subjects
    A.4.1Sponsor's protocol code numberNKT102260
    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 SponsorGlaxoSmithKline Group of Companies
    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 Information not present in EudraCT
    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 nameGW679769
    D.3.2Product code GW679769
    D.3.4Pharmaceutical form Tablet
    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 414910-30-8
    D.3.9.2Current sponsor codeGW679769
    D.3.9.3Other descriptive nameNK1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Zofran
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameZofran
    D.3.2Product code Zofran
    D.3.4Pharmaceutical form 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 INNondansetron
    D.3.9.1CAS number 116002-70-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    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
    Post Operative Nausea and Vomiting (PONV)
    Post Discharge Nausea and Vomiting (PDNV)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this clinical trial is to determine the optimal single dose of oral GW679769 when administered in combination with intravenous (IV) ondansetron hydrochloride for the prevention of emesis (defined as vomiting or retching) during the first 24 hours following the emergence from anesthesia in female subjects with known risk factors for post-operative nausea and vomiting (PONV) who are undergoing surgical procedures that are associated with an increased emetogenic risk.
    E.2.2Secondary objectives of the trial
    Determine the optimal single dose of oral GW679769 when administered in combination with IV ondansetron for the prevention of :
    1. emesis daily for up to 120 hours
    2. nausea during the first 24 hours (as assessed at 2, 6, and 24 hours)
    3.nausea daily for up to 120 hours
    following the emergence from anesthesia in female subjects undergoing surgical procedures that are associated with an increased emetogenic risk
    4.Determine the safety of oral GW679769 at various dose levels.
    5.Quantify the impact on daily life activities, as assessed by a Functional Living Index - Emesis (FLIE) questionnaire.
    6.Assess the subject satisfaction with the control of PONV and post-discharge nausea and vomiting (PDNV).
    7.Evaluate the reporting of pain experienced by subjects during the 2, 6, and 24 hour evaluation periods, and each subsequent 24 hour evaluation period (up to 120 hours).
    8.Evaluate population pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of oral GW679769.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Is a female with the following three (3) risk factors:
    •Pre-menopausal or peri-menopausal between the ages of 18-55 years, who is not of childbearing potential (i.e., physically incapable of becoming pregnant) or who demonstrates a negative serum or a negative urine pregnancy test within 24 hours prior to the first administration of study medication and agrees to:
    a)abstain from sexual intercourse for two (2) weeks prior to administration of the first dose of study medication until 30 days after the final dose of study medication, or
    b)use hormonal methods of birth control (e.g., oral, injectable, or implantable) or other highly effective method of contraception [e.g., an intrauterine device (IUD)] in conjunction with a barrier method of contraception (condom, spermicidal foam, sponge, gel, diaphragm) if engaging in sexual intercourse for at least seven (7) days prior to the first dose of study medication and continuing until 30 days after the final dose of study medication.
    •Has never smoked or used (e.g., chewing) tobacco, or has successfully quit smoking and/or using tobacco and has been a nonsmoker and nonuser (including a nicotine patch) for at least the previous twelve (12) consecutive months.
    •Known to have a history of:
    apost-operative nausea and vomiting, and/or
    bmotion sickness.
    2.Is undergoing a laparoscopic/laparotomic gynecological surgical procedure or laparoscopic cholecystectomy that is scheduled for no less than one (1) hour in duration and no longer than three (3) hours in duration.
    3.Is scheduled to receive general anesthesia with an anesthetic regimen as described in Section 4.2.
    4.Meets the American Society of Anesthesiologists (ASA) Physical Status Classification of I or II preoperatively on the day of surgery (see Section 14.5.).
    5.Has hematology and blood chemistry values within acceptable limits [i.e., within 10% outside (either above or below) normal reference values, unless otherwise specified] for surgery
    6.Is able and willing to complete daily components of the subject diary preoperatively on the day of surgery and until the end of the 120 Hour Follow-up Assessment period, and will be available to respond to follow-up by study personnel at the 120 hour study period post-emergence from anesthesia.
    7.Understands the nature and purpose of this study and the study procedures and has signed an informed consent form (ICF) for this study to indicate this understanding.
    E.4Principal exclusion criteria
    1.Meets ASA Physical Status Classification of III, IV, or V preoperatively on the day of surgery (see Section 14.5.).
    2.Is pregnant or lactating.
    3.Is post-menopausal. If the last menstrual period was within the previous eighteen (18) months, a follicle stimulating hormone (FSH) evaluation must be elevated into the postmenopausal range.
    4.Is scheduled to undergo a laparoscopic biopsy.
    5.Is scheduled to receive neuroaxial anesthesia or total intravenous volatile anesthesia (TIVA).
    6.Is scheduled to receive propofol for maintenance of anesthesia.
    7.Is scheduled to have gastric contents suctioned continuously during the surgical procedure via a nasogastric (NG) tube, or a nasogastric or oral gastric tube during the post-operative period.
    8.Has been taking more than 10 - 15 mg of oxycodone, or an equivalent opioid dose.
    9.Has received an investigational drug in the previous thirty (30) days or who is scheduled to receive any investigational drug in addition to GW679769 during the study period.
    10.Has persistant or recurrent nausea and/or vomiting due to other etiologies.
    11.Has experienced retching or vomiting or uncontrolled nausea within 48 hours prior to administration of study drug.
    12.Has experienced significant nausea in the 24 hour period prior to receiving the dose of GW679769 study medication.
    13.Has received radiation therapy to the abdomen or the pelvis in the seven days prior to receiving study medication and/or will receive radiation therapy to the abdomen or the pelvis in the evaluation period.
    14.Has a history of wound dehiscence.
    15.Has a history of previous or current peptic ulceration or inflammatory bowel disease.
    16.Has a history of any other illness, that, in the opinion of the investigator, may pose an unacceptable risk by administering study medication.
    17.Has any current or past medical condition (e.g., vagotomy) and/or require medication to treat a condition that could confound the evaluation of the data collected in this clinical trial.
    18.Has a known hypersensitivity or contraindication to ondansetron hydrochloride or ondansetron, another 5-HT3 receptor antagonist, any scheduled anesthetic or analgesic agents, or any component of GW679769.
    19.Has a known hypersensitivity to fentanyl and/or ketorolac tromethamine.
    20.Has a known allergy to eggs or egg products.
    21.Is scheduled to receive antiemetics not outlined in the study dosing scheme.
    22.Has received medication with known or potential antiemetic activity within the 24 hour period prior to receiving study drug.
    23.Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 within the following duration prior to administration of the study medication
    24.Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen (14) days prior to the administration of the study medication.
    25.Has previously received an NK-1 receptor antagonist.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the number of subjects who achieve a complete response (defined as no vomiting, no retching, no rescue therapy, and no premature discontinuation from the study) during the first 24 hour evaluation period following the emergence from anesthesia.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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
    LPLV
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 2005-12-02. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 665
    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)
    Not applicable
    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 Decision2005-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2005-08-04
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