Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Randomized, double-blind, parallel group, placebo-controlled, dose finding study in colorectal cancer patients receiving 5-FU-based chemotherapy to assess the efficacy of different doses of s.c. elsiglutide in the prevention of Chemotherapy Induced Diarrhea (CID)

    Summary
    EudraCT number
    		 2014-000998-39
    Trial protocol
    		 DE   HU   CZ   BG  
    Global end of trial date
    09 Feb 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Apr 2017
    First version publication date
    01 Apr 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TIDE-13-22
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02383810
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 73491
    Sponsors
    Sponsor organisation name
    Helsinn Healthcare SA
    Sponsor organisation address
    Via Pian Scairolo 9, Lugano/Pazzallo, Switzerland, 6912
    Public contact
    Salvatore Chessari, MSc PhD , Helsinn Healthcare SA, +41 91 985 21 21, Salvatore.Chessari@helsinn.com
    Scientific contact
    Marco Palmas, MD , Helsinn Healthcare SA, +41 91 985 21 21, Marco.Palmas@helsinn.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Dec 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to compare the efficacy of 3 subcutaneous (s.c.) doses of elsiglutide vs. placebo and vs. each other in the prevention of chemotherapy-induced diarrhea (CID) in colorectal cancer patients treated with 5 fluorouracil (5-FU)-based chemotherapy (FOLinic acid, Fluorouracil, OXaliplatin [FOLFOX] or FOLinic acid, Fluorouracil, IRInotecan [FOLFIRI regimen]) with no addition of a monoclonal antibody.
    Protection of trial subjects
    The study was conducted in full compliance with the principles of the "Declaration of Helsinki" (as amended in the 59th World Medical Association Assembly, Seoul), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines .
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 32
    Country: Number of subjects enrolled
    Czech Republic: 1
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Hungary: 37
    Country: Number of subjects enrolled
    Belarus: 31
    Country: Number of subjects enrolled
    Ukraine: 209
    Country: Number of subjects enrolled
    Russian Federation: 182
    Worldwide total number of subjects
    498
    EEA total number of subjects
    76
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    331
    From 65 to 84 years
    167
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 538 [1]
    Number of subjects completed
    		 498

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 exclusion criteria met in the Screening period: 1
    Reason: Number of subjects
    		 Randomization not within protocol visit window: 1
    Reason: Number of subjects
    		 Physician decision: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 18
    Reason: Number of subjects
    		 Inclusion/Exclusion criteria not met (cycle 1): 19
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Overall, 538 subjects were screened, a total of 498 subjects were randomized into the study ; 40 subjects were screen failures
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    Placebo and active treatments were identical in appearance. To cover the double-blind, double-dummy design, the daily administration for each of the 4 treatment groups was of 4 vials of study treatment in total including up to 4 vials of placebo in total.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Elsiglutide 10 mg - target population
    Arm description
    		 Elsiglutide 10 mg once daily as subcutanous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elsiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Elsiglutide was administered once daily as subcutaneous injection for 4 consecutive days at the dosage 10 mg/day elsiglutide.

    Arm title
    		 Elsiglutide 20 mg - target population
    Arm description
    		 Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elsiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Elsiglutide was administered once daily as subcutaneous injection for 4 consecutive days at the dosage 20 mg/day elsiglutide.

    Arm title
    		 Elsiglutide 40 mg - target population
    Arm description
    		 Elsiglutide 40 mg once daily as subcutanous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elsiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Elsiglutide was administered once daily as subcutaneous injection for 4 consecutive days at the dosage 40 mg/day elsiglutide.

    Arm title
    		 Placebo - target population
    Arm description
    		 Placebo once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy.

    Arm title
    		 Elsiglutide 10 mg - additional population
    Arm description
    		 Elsiglutide 10 mg once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elsiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Elsiglutide was administered once daily as subcutaneous injection for 4 consecutive days at the dosage 10 mg/day elsiglutide.

    Arm title
    		 Elsiglutide 20 mg - additional population
    Arm description
    		 Elsiglutide 20 mg once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elsiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Elsiglutide was administered once daily as subcutaneous injection for 4 consecutive days at the dosage 20 mg/day elsiglutide.

    Arm title
    		 Elsiglutide 40 mg - additional population
    Arm description
    		 Elsiglutide 40 mg once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elsiglutide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Elsiglutide was administered once daily as subcutaneous injection for 4 consecutive days at the dosage 40 mg/day elsiglutide.

    Arm title
    		 Placebo - additional population
    Arm description
    		 Placebo once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy.

    Number of subjects in period 1
    		Elsiglutide 10 mg - target population Elsiglutide 20 mg - target population Elsiglutide 40 mg - target population Placebo - target population Elsiglutide 10 mg - additional population Elsiglutide 20 mg - additional population Elsiglutide 40 mg - additional population Placebo - additional population
    Started
    120
    122
    120
    123
    4
    4
    3
    2
    Completed
    117
    114
    113
    112
    4
    3
    2
    2
    Not completed
    3
    8
    7
    11
    0
    1
    1
    0
         Adverse event, serious fatal
    -
    1
    2
    3
    -
    -
    -
    -
         Consent withdrawn by subject
    2
    3
    3
    3
    -
    -
    -
    -
         Physician decision
    1
    1
    -
    -
    -
    -
    -
    -
         subject did not receive study treatment
    -
    1
    -
    -
    -
    -
    -
    -
         Adverse event, non-fatal
    -
    1
    2
    2
    -
    1
    1
    -
         Other
    -
    -
    -
    2
    -
    -
    -
    -
         Lost to follow-up
    -
    1
    -
    1
    -
    -
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 498 498
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (standard deviation)
    		 61 ( 9.88 ) -
    Gender categorical
    Units: Subjects
        Female
    		 266 266
        Male
    		 232 232
    Subject analysis sets

    Subject analysis set title
    FAS Target set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) was defined as all randomized patients who received at least 1 dose of study medication (elsiglutide or placebo) and (at least part of) the chemotherapy regimen in Cycle 1. The FAS Target set was defined as all patients from the Target population who were eligible for the FAS.

    Subject analysis sets values
    		 FAS Target set
    Number of subjects
    484
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (standard deviation)
    61 ( 9.93 )
    Gender categorical
    Units: Subjects
        Female
    258
        Male
    226

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Elsiglutide 10 mg - target population
    Reporting group description
    		 Elsiglutide 10 mg once daily as subcutanous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy

    Reporting group title
    Elsiglutide 20 mg - target population
    Reporting group description
    		 Elsiglutide 20 mg once daily as s.c. injection for 4 consecutive days in patients receiving F-FU based chemotherapy.

    Reporting group title
    Elsiglutide 40 mg - target population
    Reporting group description
    		 Elsiglutide 40 mg once daily as subcutanous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy.

    Reporting group title
    Placebo - target population
    Reporting group description
    		 Placebo once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy.

    Reporting group title
    Elsiglutide 10 mg - additional population
    Reporting group description
    		 Elsiglutide 10 mg once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

    Reporting group title
    Elsiglutide 20 mg - additional population
    Reporting group description
    		 Elsiglutide 20 mg once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

    Reporting group title
    Elsiglutide 40 mg - additional population
    Reporting group description
    		 Elsiglutide 40 mg once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

    Reporting group title
    Placebo - additional population
    Reporting group description
    		 Placebo once daily as subcutaneous injection for 4 consecutive days in patients receiving 5-FU based chemotherapy with monoclonal antibody.

    Subject analysis set title
    FAS Target set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) was defined as all randomized patients who received at least 1 dose of study medication (elsiglutide or placebo) and (at least part of) the chemotherapy regimen in Cycle 1. The FAS Target set was defined as all patients from the Target population who were eligible for the FAS.

    Primary: Proportion of Patients of the Target Population Experiencing a Maximum Grade ≥ 2 Diarrhea in Cycle 1 (Population: FAS Target Set)

    		 Close Top of page
    End point title
    		 Proportion of Patients of the Target Population Experiencing a Maximum Grade ≥ 2 Diarrhea in Cycle 1 (Population: FAS Target Set) [1]
    End point description
    The endpoint of primary interest for efficacy was the proportion of patients within the Target population experiencing a maximum Grade ≥ 2 diarrhea in Cycle 1 (as assessed by the Investigator). For patient 8031362 who withdrew consent after 11 days in Cycle 1, Investigator assessments for the individual diarrhea events were missing.The data were imputed as Grade 0 for the primary endpoint, in line with the patient’s eDiary data. Grade of diarrhea according to NCI-CTCAE v 4.03 scale. Maximum grade: Maximum of the grades assigned by the Investigator to the individual diarrhea events during the 14-day period. p-value 2: Chi square test, with alpha = 0.10 (2-sided) p-value 3 : Corrected for multiplicity according to Hommel’s procedure Chi square test, with alpha = 0.10 (2 sided); this is the analysis used to test for treatment superiority
    End point type
    Primary
    End point timeframe
    Cycle 1 was foreseen to last 14 days.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The endpoint of primary interest for efficacy was the proportion of patients within the Target population experiencing a maximum Grade ≥ 2 diarrhea in Cycle 1 (as assessed by the Investigator).
    End point values
    		 Elsiglutide 10 mg - target population Elsiglutide 20 mg - target population Elsiglutide 40 mg - target population Placebo - target population
    Number of subjects analysed
    120
    121 [2]
    120
    123
    Units: percentage
    number (not applicable)
        With maximum Grade ≥ 2 diarrhea
    2.5
    5
    5.8
    9.8
        With maximum Grade < 2 diarrhea
    97.5
    95
    94.2
    90.2
        p-value2 (comparison vs. placebo)
    0.019
    0.152
    0.255
    0
        p-value2 (comparison vs. elsiglutide 10 mg)
    0
    0.314
    0.196
    0
        p-value2 (comparison vs. elsiglutide 20 mg)
    0
    0
    0.764
    0
        p-value3 (comparison vs. placebo)
    0.113
    0.455
    0.51
    0
        p-value3 (comparison vs. elsiglutide 10 mg)
    0
    0.628
    0.471
    0
        p-value3 (comparison vs. elsiglutide 20 mg)
    0
    0
    0.764
    0
    Notes
    [2] - One subject was discontinued on the date of randomization and did not receive study treatment
    Statistical analysis title
    		 Chi square test
    Statistical analysis description
    Overall null hypothesis: All elsiglutide dose groups had equal proportion of subjects with max Grade≥2 diarrhea and this was equal to the one in the placebo group. This includes 6 individual hypotheses (i.e., 3 to compare each dose group vs. placebo and 3 to compare dose groups vs. each other). Raw p-values from Chi square tests were corrected for multiplicity according to the Hommel’s procedure. Each of 6 hypotheses was then evaluated based on corrected p-value at alpha 0.10 (two-sided).
    Comparison groups
    Elsiglutide 10 mg - target population v Elsiglutide 20 mg - target population v Elsiglutide 40 mg - target population v Placebo - target population
    Number of subjects included in analysis
    484
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.1 [4]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [3] - The overall hypothesis system was represented by the following pool of partial hypothesis systems: Hok: πGi = πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j HAk: πGi ≠πGj i = 1 to 3, and j = 2 to 4, and k = 1 to 6, and i ≠ j where πG is the probability of absence of Grade ≥2 CID for the Group. Each Ho involved 2 groups.
    [4] - Overall alpha level 0.10 was maintained by correction for multiplicity according to Hommel’s procedure.

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    23 Jan 2015 to 09 Feb 2016
    Adverse event reporting additional description
    The safety (SAF) set was defined as all treated patients. “Patients treated” was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set). Adverse events are reported for Cycles 1+2.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Elsiglutide 10 mg - SAF Overall set
    Reporting group description
    		 Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. “Patients treated” was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).

    Reporting group title
    Elsiglutide 20 mg - SAF Overall set
    Reporting group description
    		 Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. “Patients treated” was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).

    Reporting group title
    Elsiglutide 40 mg - SAF overall set
    Reporting group description
    		 Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. “Patients treated” was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).

    Reporting group title
    Placebo - SAF overall set
    Reporting group description
    		 Adverse events occurring during Cycle 1 + 2 are reported. The safety (SAF) set was defined as all treated patients. “Patients treated” was defined as any patient who received any study medication (elsiglutide or placebo) on at least 1 day. The SAF Overall set was defined as all patients who were part of the SAF (either of SAF Target set or of SAF Additional set).

    Serious adverse events
    		 Elsiglutide 10 mg - SAF Overall set Elsiglutide 20 mg - SAF Overall set Elsiglutide 40 mg - SAF overall set Placebo - SAF overall set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 124 (1.61%)
    4 / 125 (3.20%)
    3 / 123 (2.44%)
    6 / 125 (4.80%)
         number of deaths (all causes)
    1
    1
    2
    3
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Investigations
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 123 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypovolaemic shock
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    1 / 123 (0.81%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 123 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    1 / 123 (0.81%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Disease progression
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    2 / 125 (1.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Soft tissue inflammation
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 123 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 123 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 125 (0.80%)
    1 / 123 (0.81%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus urethral
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 125 (0.00%)
    0 / 123 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Elsiglutide 10 mg - SAF Overall set Elsiglutide 20 mg - SAF Overall set Elsiglutide 40 mg - SAF overall set Placebo - SAF overall set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    71 / 124 (57.26%)
    68 / 125 (54.40%)
    73 / 123 (59.35%)
    72 / 125 (57.60%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 124 (4.84%)
    7 / 125 (5.60%)
    7 / 123 (5.69%)
    9 / 125 (7.20%)
         occurrences all number
    6
    8
    9
    14
    Leukopenia
         subjects affected / exposed
    6 / 124 (4.84%)
    10 / 125 (8.00%)
    6 / 123 (4.88%)
    12 / 125 (9.60%)
         occurrences all number
    6
    11
    6
    13
    Neutropenia
         subjects affected / exposed
    32 / 124 (25.81%)
    29 / 125 (23.20%)
    26 / 123 (21.14%)
    32 / 125 (25.60%)
         occurrences all number
    44
    34
    34
    44
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    9 / 124 (7.26%)
    8 / 125 (6.40%)
    7 / 123 (5.69%)
    7 / 125 (5.60%)
         occurrences all number
    11
    9
    9
    13
    Injection site erythema
         subjects affected / exposed
    1 / 124 (0.81%)
    3 / 125 (2.40%)
    10 / 123 (8.13%)
    0 / 125 (0.00%)
         occurrences all number
    3
    4
    33
    0
    Gastrointestinal disorders
    Abdominal tenderness
         subjects affected / exposed
    0 / 124 (0.00%)
    11 / 125 (8.80%)
    7 / 123 (5.69%)
    7 / 125 (5.60%)
         occurrences all number
    0
    37
    17
    19
    Nausea
         subjects affected / exposed
    21 / 124 (16.94%)
    17 / 125 (13.60%)
    15 / 123 (12.20%)
    17 / 125 (13.60%)
         occurrences all number
    27
    23
    23
    23
    Vomiting
         subjects affected / exposed
    1 / 124 (0.81%)
    3 / 125 (2.40%)
    7 / 123 (5.69%)
    5 / 125 (4.00%)
         occurrences all number
    2
    3
    8
    5

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Dec 2014
    The protocol for this study was amended once. This amendment was implemented before the first patient was included in the study. Reasons for Amendment 1, dated 02 Dec 2014 were: • It was clarified that exclusion criteria 17 to 23 were to be checked on Day 1 of Cycle 1 as well as Day 1 of Cycle 2. • It was clarified that the Investigator is not kept blinded with regards to the patient’s judgment about the occurrence of diarrhea. • The reporting of diarrhea events in the context of AE reporting was clarified. • It was defined that elsiglutide AEs included in the MedDRA high level term “injection site reactions” will be considered as AEs of special interest. • It was clarified that only IWRS, no Interactive Voice Response System was used in the study. • It was clarified that preventive measures against CID other than medications are permitted. • The nomenclature and use of documents was clarified for the Drug Preparation Form and the IWRS randomization confirmation e-mail. • It was clarified that urinalysis will not be restricted to dipstick analysis and that results for urine sample analysis did not have to be available for administration of study treatment on Day 1 to commence. • The description of the statistical analysis for QoL data and for vital signs data was corrected. • The Declaration of Helsinki was removed from the list of appendices and instead included in the list of references. • Administrative information and administrative changes: - The bioanalytical laboratory for citrulline testing and the company responsible for clinical trial supplies, packaging, and labelling were mentioned. - The contact details of sponsor representatives were adapted to show the actual address instead of a post-box address. • Minor text changes were implemented to clarify information, improve readability and remove incorrect or ambiguous wording.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 06 21:18:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA