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    Summary
    EudraCT Number:2015-004019-19
    Sponsor's Protocol Code Number:MDCO-ABP-15-01
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-04-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-004019-19
    A.3Full title of the trial
    A phase II, two-part, multiple-dose, dose-finding, single-blind study to investigate the safety and efficacy of ABP-700 for procedural sedation in adult patients undergoing colonoscopy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in patients undergoing colonscopy to investigate the efficacy and safety of ABP-700 and to optimize the infusion dose.
    A.4.1Sponsor's protocol code numberMDCO-ABP-15-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Medicines Company
    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 supportThe Medicines Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Medicines Company
    B.5.2Functional name of contact pointSteven Sweeney
    B.5.3 Address:
    B.5.3.1Street Address8 Sylvan way
    B.5.3.2Town/ cityParsippany
    B.5.3.3Post codeNJ 07054
    B.5.3.4CountryUnited States
    B.5.6E-mailsteve.sweeney@themedco.com
    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 nameABP-700
    D.3.2Product code ABP-700
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeABP-700
    D.3.9.3Other descriptive nameABP-700
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sedation during elective colonoscopy
    E.1.1.1Medical condition in easily understood language
    Sedation during elective colonoscopy
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 assess the dose-response relationship, efficacy and safety of ABP-700 for procedural sedation in adult patients undergoing colonoscopy.
    • To quantify the pharmacodynamic effect of ABP-700 including time to procedure start, sedation depth, patient recovery and readiness for discharge
    • To quantify the cardio-respiratory effects of sedation doses of ABP-700
    E.2.2Secondary objectives of the trial
    Exploratory objectives:
    To determine endoscopist and anesthesiologist satisfaction with the procedure
    To determine patient satisfaction with the procedure
    To determine patient procedural recall.
    To evaluate cognition and memory function of the patient.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient must be male or female 18 -75 years of age, inclusive.
    2. Patient must give written informed consent before initiation of any study-related procedures
    3. Patient is scheduled to undergo elective colonoscopy
    4. BMI 18.0 – 29.0 kg/m2
    5. ASA class I – II
    6. Modified Mallampati score I – II
    E.4Principal exclusion criteria
    1. Any ASA physical status III or worse, or history of one or more of the following:
    - History or presence of significant cardiovascular disease including atrial fibrillation, or cardiovascular disease risk factors, hyperlipidemia, coronary artery disease, or any known genetic pre disposition to cardiac arrhythmia (including long QT syndrome, > 450 msec)
    - History of any neurological or seizure disorder or psychiatric disease
    - History or presence of significant pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic or dermatologic disease
    - History of any illness that, in the opinion of the PI, might confound the results of the study or pose an additional risk to the patient by their participation in the study
    2. History of any recent illness (e.g., upper respiratory infection) that does not satisfy ASA III or greater requirements but in the opinion of the PI, may pose an additional risk to the patient by their participation in the study.
    3. Patients with a history of essential hypertension that are not well on controlled on medication and/or have been diagnosed with hypertension for less than 6 months and/or are not on stable therapy for at least 4 weeks prior to the study
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints:
    • Number of successfully completed procedures by assigned ABP-700 infusion dose. Success defined as patients who meet the following 2 criteria:
    • Procedure completion
    • No significant respiratory depression as assessed by oxygen saturation decrease to less than 90% and no need for assisted positive pressure ventilation (manual or mechanical)
    • Number of successfully completed procedures (as above) by assigned ABP-700 infusion dose with and without bolus ABP-700 adjustment
    • Number of successfully completed procedures by assigned ABP-700 infusion dose with and without bolus ABP-700 adjustment that require or do not require rescue sedative medication.
    • Time to procedure start
    • Depth and duration of sedation
    • Number of supplemental ABP-700 bolus doses required
    Recovery from sedation and discharge conditions as assessed by the Modified Aldrete score (APRS)

    Safety endpoints:
    • Quantification of hemodynamics to include frequency of adverse events and change from baseline for heart rate, blood pressure and ECG parameters (e.g. QTc)
    • Frequency of MOAA/S <3 (deep sedation events)
    • Frequency of respiratory depression (< 8 breaths per minute), arterial desaturation (SpO2 < 90%), apnea (> 30s) and patients who require maneuvers to open or maintain the airway (e.g. chin lift, jaw thrust) and any mechanical or hand assisted ventilatory support'
    • Frequency of injection site reactions
    • Frequency of (S)AEs
    • Frequency of clinically relevant laboratory findings (hematology, biochemistry)

    Exploratory endpoints:
    • Patient satisfaction with the procedure
    • Proceduralist satisfaction (endoscopist and anesthesiologist)
    • Procedural recall as measured by the Modified Brice questionnaire
    Time to full cognitive recovery as measured by PQRS (cognitive domain only)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the procedure or before discharge
    E.5.2Secondary end point(s)
    N.A.
    E.5.2.1Timepoint(s) of evaluation of this end point
    N.A.
    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 No
    E.6.7Pharmacodynamic Yes
    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) 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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Different dose of same IMP
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States No
    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 No
    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
    Last subject last follow up
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state75
    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 Decision2016-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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