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    Summary
    EudraCT Number:2005-005855-16
    Sponsor's Protocol Code Number:NKT102552
    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:2006-05-08
    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 number2005-005855-16
    A.3Full title of the trial
    A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis
    A.4.1Sponsor's protocol code numberNKT102552
    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 Research and Development Ltd
    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 Powder for Injection 30mg/vial
    D.3.2Product code GW679769
    D.3.4Pharmaceutical form Powder 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.3.9.1CAS number 414910-30-8
    D.3.9.2Current sponsor codeGW679769
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product 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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Zofran i.v. 4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Intravenous 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 INNOndansetron
    D.3.9.1CAS number 116002-70-1
    D.3.9.3Other descriptive nameZofran
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 placeboPowder for infusion*
    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
    Postoperative Nausea and Vomiting (PONV)
    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 study is to demonstrate the superiority of 30 mg intravenous GW679769, in combination with a single 4 mg intravenous dose of ZOFRAN (ondansetron hydrochloride), over a single 4 mg intravenous dose of ZOFRAN (ondansetron hydrochloride) alone in the control of emesis during the first 24 hours following placement of the last suture/staple (as measured by complete response, defined as no vomiting, no retching, no rescue medications) in surgical subjects who are predicted to have a high risk of emesis.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this clinical trial are to:

    Assess the severity of nausea experienced by subjects in each cohort during the 2, 6, 24 and 48 hour periods.

    Assess the control of emesis in the 24-48 hour period following placement of the last suture/staple.

    Assess subject satisfaction with the prophylactic antiemetic regimens, and the willingness of subjects to use the same regimens for future surgical procedures.

    Determine the safety and tolerability of the antiemetic regimens in surgical subjects who are predicted to have a high risk of emesis.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. is 18 years of age or older
    2. has all four Apfel risk factors:
    •female gender
    •a history of PONV and/or motion sickness
    •a non-smoker: defined for this study as one who has not smoked or used (e.g., chewing) tobacco (including a nicotine patch or other nicotine-withdrawal formulation) for at least the previous 6 months.
    •anticipated to receive opioids postoperatively
    3. is scheduled to undergo one of the following surgical procedures: breast surgery, orthopaedic shoulder surgery, or thyroid surgery. The following laparoscopic or laparotomic procedures are also permitted: cholecystectomy, hysterectomy, or other gynaecologic surgery
    4. surgery must be anticipated to involve general anesthesia of at least one hour duration.
    5. scheduled to receive general inhalation anesthesia with an anesthetic regimen as described in the protocol under Section 4.2., “Anesthetic and Analgesic Regimen”.
    6. meets the American Society of Anesthesiologists (ASA) Physical Status Classification of P1 or P2, preoperatively, on the day of surgery.
    7. willing and expected to be able to complete daily components of the subject diary preoperatively on the day of surgery and until the end of the 48 hour assessment period, and return to the investigational site at the post-op Day 6-14 final study visit.
    8. understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
    9. women of childbearing potential must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
    a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is postmenopausal. For purposes of this study, postmenopausal is defined as one year without menses). These subjects do not need to follow the birth control practices outlined in this protocol.
    b. child-bearing potential: has a negative serum pregnancy test result or a negative urine dipstick pregnancy test at baseline (within 24 hours prior to investigational product administration) and agrees to one of the following:
    • male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
    • oral contraceptives (either combined or progestogen only) which must be combined with double-barrier method of contraception consisting of spermicide with either condom or diaphragm
    • double-barrier method of contraception consisting of spermicide with either condom or diaphragm
    • intra-uterine device (IUD) with a documented failure rate of less than 1% per year
    • complete abstinence from intercourse for two weeks prior to exposure to the investigational product throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days after exposure to the investigational product, equivalent to five half-lives)
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. is pregnant or lactating
    2. is scheduled to receive propofol for maintenance of anesthesia
    3. has received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug in addition to GW679769 during the study period
    4. has persistent or recurrent nausea and/or vomiting due to other etiologies
    5. is taking greater than 10 mg of oxycodone, or an equivalent opioid dose, on a regular, daily basis, for more than three consecutive days prior to entry into the study.
    6. has a medical condition (e.g., vagotomy) or is receiving medication that could confound the results of this study
    7. is anticipated to require a nasogastric or oral-gastric tube with intermittent or continuous suctioning post-operatively
    8. has baseline ALT/AST >1.5x the upper limit of normal, unless due to the condition for which the subject is undergoing surgery, in which case the acceptable limit is 3x the upper limit of normal
    9. has baseline bilirubin >1.5x the upper limit of normal, unless due to the condition for which the subject is undergoing surgery, in which case the acceptable limit is 3x the upper limit of normal
    10. has a known hypersensitivity to ondansetron, another 5-HT3 receptor antagonist, any component of GW679769, or any of the scheduled anesthetic or analgesic agents
    11. is scheduled to receive antiemetics not included in the study dosing scheme, during the evaluation period, or has received medication with potential antiemetic activity in the 24 hour period, (or as specified below), prior to surgery. This includes, but is not limited to:
    • 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonosetron is not permitted for seven days prior to the study.
    • benzamide/benzamide derivatives (e.g., metoclopramide, alizapride)
    • phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine)
    • butyrophenones (e.g., haloperidol, droperidol)
    • corticosteroids (e.g., dexamethasone, methylprednisolone – with the exception of topical steroids for skin and/or ocular disorders and inhaled steroids for respiratory disorders)
    • scopolamine
    • antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine); however, diphenhydramine for pruritis is allowed
    • domperidone
    • cannabinoids
    12. has taken/received strong or moderate inhibitors of CYP3A4 and/or CYP3A5 within the following time frames prior to administration of the investigational product, or during the 48 hour assessment period:
    2 days: clarithromycin, diltiazem, erythromycin, ketoconazole, verapamil
    14 days: fluconazole, itraconazole
    13. has taken /received inducers of CYP3A4 and/or CYP3A5 within 14 days prior to the administration of the investigational product, or during the 48 hour assessment period, including: carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St. John’s wort, and troglitazone
    14. is taking the anti-diabetic agent repaglinide or the diuretic torsemide. Investigators are advised to exercise caution if including patients taking the anti-diabetic agents rosiglitazone or pioglitazone, or antimalarial agents such as chloroquine and amodiaquine, as the metabolite of GW679769 is a potential inhibitor of CYP2C8.
    15. In France, a subject is neither affiliated with nor a beneficiary of a social security category.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the proportion of subjects who achieve a complete response (defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple).
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 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.8.6 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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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 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 2006-05-08. 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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 462
    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)
    There are no plans for subjects in NKT102552 to be offered study drug after completion of the study. GW679769 does not currently have marketing authorisation approval in any market. Following completion of the study the subject’s physician will be responsible for ensuring the subject receives the appropriate care and treatment.
    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 Decision2005-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-07-06
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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