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    Summary
    EudraCT Number:2007-006549-42
    Sponsor's Protocol Code Number:EN3285-302
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-03-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-006549-42
    A.3Full title of the trial
    A Phase 3, Multinational, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Subjects with Head and Neck Cancer Receiving Chemoradiotherapy
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberEN3285-302
    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 SponsorEndo Pharmaceuticals Inc.
    B.1.3.4CountryUnited States
    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 nameNAC ProGelz® (NAC Oromucosal Liquid)
    D.3.2Product code EN3285
    D.3.4Pharmaceutical form Oromucosal liquid*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 616-91-1
    D.3.9.2Current sponsor codeEN3285
    D.3.9.3Other descriptive nameN-Acetylcysteine
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    D.3.11.13.1Other medicinal product typeMucolytic therapy medicinal product
    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 placeboOromucosal liquid*
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Severe Oral Mucositis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028130
    E.1.2Term Mucositis oral
    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 evaluate the relative efficacy of EN3285 compared with placebo in the delay to onset of severe (NCI grade >2) OM. The coprimary objective of this study is to evaluate the relative efficacy of EN3285 compared with placebo in prevention of severe (NCI grade >2) OM at a cumulative dose of 50 Gy.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare EN3285 with placebo with respect to:
    • Safety through the collection of AEs and laboratory data
    • Delaying the onset of severe OM (WHO grade >2)
    • Prevention of severe OM (WHO grade >2)
    • Percent of time (days) spent on opiates for oral pain during the course of RT
    • Reducing the need for interventional placement of feeding tubes for nutritional support due to OM
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects will be included in the study if they:
    • Are 18 years and older with newly diagnosed clinically and histologically confirmed SCC of the oral cavity and/or oropharynx, and are intended for treatment with ChemoRT. (Subjects with unknown primary tumors are allowed depending on target RT as defined below as well as postoperative subjects.)
    • Have a clinical plan to receive a minimum of 60 Gy to the oral cavity and/or oropharynx using any of the following:
    – Standard fractionation to deliver 1.8 to 2.2 Gy per day in a single fraction
    – Intensity Modulated Radiotherapy (IMRT) and Helio IMRT are allowed
    • Will receive chemotherapy consisting of one of the following regimens:
    – Cisplatin 80 - 100 mg/m2 in 21-day cycles
    – Weekly cisplatin 30 mg/m2
    • Have a WBC ≥3500 per cubic millimeter
    • Have a platelet count ≥100,000 per cubic millimeter
    • Have adequate renal function as determined by the principal investigator prior to enrollment
    • Are willing and able to undergo oral assessments
    • Have a Karnofsky Performance Status score ≥70
    • Have the ability to understand the protocol and provide informed consent
    • If female and of childbearing potential, must have negative serum pregnancy test
    • If female, must be practicing abstinence or using a medically acceptable form of contraception (eg, intrauterine device, hormonal birth control, or double barrier method). For this study, all females are considered to be of childbearing potential unless they are post-menopausal (at least 1 year since last menses), biologically sterile, or surgically sterile (ie, hysterectomy, bilateral oophorectomy or tubal ligation).
    E.4Principal exclusion criteria
    Subjects will be excluded from participation in the study if they:
    • Have OM or other oral conditions that would preclude a complete and accurate assessment of OM during treatment at study entry
    • Are using a pre-existing feeding tube for nutritional support at study entry
    • Plan to use Amifostine, Pilocarpine, Cevimeline and Bethanechol
    • Plan to use any drug for the treatment or prevention of OM (including topical steroids and topical anti-inflammatory agents such as Benadryl) except for analgesics and other treatments identified as acceptable in the protocol (see Section 5.5)
    • Have had any prior radiotherapy to the head and neck
    • Have intent to treat with daily hyperfractionated RT regimens, brachytherapy or interstitial implantation, or any form of boost where the daily dose exceeds 2.2 Gy.
    • Have had prior chemotherapy within 6 months preceding enrollment
    • Plan to have concurrent chemotherapy, other than those regimens specified under inclusion criteria
    • Have received other investigational drugs in the 30 days preceding initiation of study drug or during administration of study drug
    • Have medical conditions that require the use of chronic steroid therapy
    • Have a recent, serious, nonmalignant medical condition that, in the opinion of the principal investigator, makes the subject unsuitable for study participation (eg, subjects who are immunocompromised)
    • In the opinion of the principal investigator, have a medical, sociological, or psychological impediment to probable compliance with protocol
    • Have the inability to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be radiation dose to onset of severe OM (NCI grade >2) over the cumulative dose range 0 to 50 Gy.

    The coprimary endpoint will be the proportion of subjects with severe OM (NCI grade >2) at a cumulative dose of 50 Gy.

    The study will enroll subjects who are scheduled to receive a minimum cumulative RT dose of 60 Gy during a treatment period of up to 8 weeks. Due to the high variability of the treatment regimens not only across centers, but between subjects, this study will look at group comparisons up to and at a cumulative RT dose of 50 Gy.
    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 No
    E.6.7Pharmacodynamic No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 years2
    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 years2
    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) 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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-04-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-08
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