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    Summary
    EudraCT Number:2004-001814-14
    Sponsor's Protocol Code Number:ABD101684
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-11-03
    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 ConcernedFinland - Fimea
    A.2EudraCT number2004-001814-14
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects.
    A.4.1Sponsor's protocol code numberABD101684
    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 R&D Limited
    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 namealvimopan
    D.3.2Product code SB-767905
    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 INNalvimopan
    D.3.9.1CAS number 170098-38-1
    D.3.9.2Current sponsor codeSB-767905-KW
    D.3.9.3Other descriptive namealvimopan, BX2, piperglycine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalvimopan
    D.3.9.1CAS number 170098-38-1
    D.3.9.2Current sponsor codeSB-767905-KW
    D.3.9.3Other descriptive namealvimopan, BX2, piperglycine
    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 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 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
    Opioid-Induced Bowel Dysfunction
    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
    To compare the safety among the treatment regimens, while offering continued access to blinded investigational product to subjects who have completed a prior GSK alvimopan OBD study in cancer pain subjects.
    E.2.2Secondary objectives of the trial
     To demonstrate the lack of effect of the treatment regimens on opioid analgesia
     To compare OBD global improvement
     To compare treatment satisfaction
     To compare maintenance stool softener and rescue laxative use
     To describe the steady-state population pharmacokinetics of alvimopan and its main metabolite when alvimopan is dosed orally either once or twice daily
     To quantify the disease burden of OBD via the PAC-QOL
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Those who have completed a GSK alvimopan OBD study in cancer pain subjects (e.g., study SB-767905/008).
    2. Taking chronic opioid therapy for cancer pain (note: permanent discontinuation of chronic opioid therapy during the study requires that the subject be discontinued from the study). The opioid therapy must meet the following conditions:
    - comprised of a full agonist opioid
    - administered orally, transdermally, intravenously, or subcutaneously
    - dosed chronically for at least one month prior to the Screening Visit at a minimum daily dose of at least 30 mg oral morphine equivalents
    3. Those who met the protocol-defined criteria for having OBD in the original study and, who in the investigator’s opinion, continues to require therapy or management of OBD.
    4. Those who understand the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities, including discontinuation of pre-study laxative regimen or other prohibited medications. Given the likely clinical progression due to cancer and limited life expectancy for many of these subjects, there is no requirement that the subject’s consent implies participation for the entire duration of the Treatment Period.
    5. Capable of completing the paper questionnaires.
    6. If female , then the subject is currently either of:
    a) non-childbearing potential
    b) child-bearing potential, has a negative B-hCG pregnancy test (either urine or serum) at the Screening Visit (prior to investigational product), and agrees to use acceptable contraception throughout the study.
    E.4Principal exclusion criteria
    1. Pregnant or lactating, or planning to become pregnant during the study.
    2. Have participated in another trial with an investigational drug, device or procedure within 30 days prior to the Screening Visit, with the exception of another GSK alvimopan OBD studies in cancer pain subjects. Subject has been assigned to investigational product in this study (ABD101684) at anytime in the past.
    3. Unable to eat or drink. Subjects who are unable to take oral medications or to hold down oral medications due to vomiting are excluded.
    4. Taking opioids for the management of drug addiction.
    5. Taking opioids that are mixed agonists/antagonists or partial agonists.
    6. Unable or unwilling to discontinue the use of and/or refrain from using stool softeners and laxatives of all types and formulation (i.e., hyperosmotics, mineral oil, saline, stimulants, suppositories, lubricants, enemas, or any other natural products that promote bowel motility/cleansing) at the Treatment Assignment Visit and throughout the entire study. NOTE - Should a laxative regimen be needed, GlaxoSmithKline will provide the subject with a standardized maintenance stool softener and rescue laxative for use throughout the study.
    7. Has severe constipation that has not been appropriately managed such that the subject is at immediate risk of developing serious complications.
    8. Have GI or pelvic disorders known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction
    9. Currently taking vinca alkaloids or plans to take vinca alkaloids during the study. Subject who has experienced paralytic ileus or intestinal pseudoobstruction associated with past chemotherapy treatment
    10. In the investigator’s opinion, has bowel dysfunction that is predominantly resulting from causes other than the chronic use of opioids
    11. Have chronic fecal incontinence.
    12. Taking antidiarrheals (e.g., loperamide), has an incidence of diarrhea or loose stools in the 2 weeks prior to the Screening Visit or a history of intermittent diarrhea, loose stools or irritable bowel syndrome (IBS) symptoms which are consistent with the Rome II Criteria.
    13. Have active viral hepatitis (any subtype including ongoing chronic hepatitis B) or has ever been infected with hepatitis C.
    14. Have undergone prior radiation therapy that resulted in documented chronic radiation enteritis or radiation stricture, has undergone abdominal radiation therapy in the 2 weeks prior to the Screening Visit, is currently undergoing abdominal radiation therapy and/or plans to undergo abdominal radiation therapy during the study.
    15. Have clinically significant laboratory abnormalities prior to Treatment Assignment suggestive of of primary hepatic dysfunction or active viral hepatitis, renal impairment andany other condition that would contraindicate participation in this study
    16. Have a history of alcohol and/or substance abuse within the past 2 years.
    17. Taking a concomitant medication or has any other known condition or physical examination finding prior to Treatment Assignment, which could contraindicate participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of reported adverse events, including serious adverse events.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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.8.6 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
    The end of the trial will be the last visit of the last subject.
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    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 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 2005-11-03. 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 195
    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)
    None
    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 Decision2005-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-04-09
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