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    Clinical Trial Results:
    Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer – Cachexia (NSCLC-C): A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients with NSCLC-C

    Summary
    EudraCT number
    		 2010-023649-31
    Trial protocol
    		 HU   GB   PL  
    Global end of trial date
    10 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2016
    First version publication date
    28 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HT-ANAM-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01387282
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Other: ROMANA 2
    Sponsors
    Sponsor organisation name
    Helsinn Therapeutics (US), Inc.
    Sponsor organisation address
    170 Wood Avenue South, 5th Floor, Iselin, NJ, United States, 08830
    Public contact
    Richard K. Bourne, Ph.D., Helsinn Therapeutics (US), Inc., +1 732-603-2852, richard.bourne@helsinn.com
    Scientific contact
    Richard K. Bourne, Ph.D., Helsinn Therapeutics (US), Inc., +1 732-603-2852, richard.bourne@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
    04 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate the effect of Anamorelin HCl on lean body mass (LBM) as measured by dual energy X-ray absorptiometry (DXA) 2. To evaluate the effect of Anamorelin HCl on muscle strength as measured by handgrip strength (HGS)
    Protection of trial subjects
    The study was designed and monitored in accordance with Sponsor procedures, which comply with the ethical principles of Good Clinical Practice (GCP) as required by the major regulatory authorities, and in accordance with the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Jul 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 203
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    Hungary: 108
    Country: Number of subjects enrolled
    Australia: 22
    Country: Number of subjects enrolled
    Israel: 13
    Country: Number of subjects enrolled
    Russian Federation: 133
    Country: Number of subjects enrolled
    United States: 15
    Worldwide total number of subjects
    495
    EEA total number of subjects
    312
    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)
    317
    From 65 to 84 years
    178
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index [BMI] < 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.

    Pre-assignment
    Screening details
    		 Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablets.

    Arm title
    		 Anamorelin HCl
    Arm description
    		 Active drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Anamorelin HCl
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Anamorelin HCl; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.

    Number of subjects in period 1
    		Placebo Anamorelin HCl
    Started
    165
    330
    Completed
    118
    233
    Not completed
    47
    97
         Unrelated AE
    4
    6
         Lost to follow-up
    1
    4
         Death
    16
    47
         Other
    1
    5
         Study drug-related AE
    2
    2
         Withdrawal by patient
    23
    33

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 Active drug

    Reporting group values
    		 Placebo Anamorelin HCl Total
    Number of subjects
    		 165 330 495
    Age categorical
    Units: Subjects
        ≤ 65 years
    		 108 209 317
        > 65 years
    		 57 121 178
    Gender categorical
    Units: Subjects
        Female
    		 43 90 133
        Male
    		 122 240 362
    Race
    Units: Subjects
        White
    		 162 326 488
        Black or African American
    		 1 2 3
        Asian
    		 1 0 1
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Other
    		 1 1 2
    Geographic region
    Units: Subjects
        North America
    		 5 10 15
        West Europe
    		 75 142 217
        East Europe + Russia
    		 77 164 241
        Australia
    		 8 14 22

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 Active drug

    Subject analysis set title
    ITT Population
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The ITT Population included all randomized patients.

    Subject analysis set title
    MITT Population
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The MITT Population included all randomized patients who received any study drug and for whom at least 1 post-baseline co-primary efficacy variable (LBM or HGS) observation was obtained.

    Primary: Change in Lean Body Mass

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    End point title
    		 Change in Lean Body Mass
    End point description
    Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
    End point type
    Primary
    End point timeframe
    Change in Lean Body Mass from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    157
    321
    Units: kg
        median (confidence interval 95%)
    -0.98 (-1.49 to -0.41)
    0.65 (0.38 to 0.91)
    Statistical analysis title
    		 LBM statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Primary: Change in Handgrip Strength

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    End point title
    		 Change in Handgrip Strength
    End point description
    Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.
    End point type
    Primary
    End point timeframe
    Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    157
    321
    Units: kg
        median (confidence interval 95%)
    -0.95 (-1.56 to 0.04)
    -1.49 (-2.06 to -0.58)
    Statistical analysis title
    		 HGS statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    478
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.648
    Method
    		 Wilcoxon rank sum test
    Confidence interval

    Secondary: Change in A/CS Domain Score from Baseline

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    End point title
    		 Change in A/CS Domain Score from Baseline
    End point description
    Change in the Functional Assessment of Anorexia/Cachexia Treatment (FAACT) 12-item Additional Concerns Subscale (A/CS) domain score from baseline overall (i.e., over 12 weeks) for the MITT Population.
    End point type
    Secondary
    End point timeframe
    Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    136
    268
    Units: score
        least squares mean (standard error)
    1.34 ± 1.032
    3.48 ± 0.944
    Statistical analysis title
    		 FAACT A/CS statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0016
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in FACIT-F Fatigue Domain Score

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    End point title
    		 Change in FACIT-F Fatigue Domain Score
    End point description
    Change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) domain score from baseline overall (i.e., over 12 weeks) for the MITT Population.
    End point type
    Secondary
    End point timeframe
    Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    136
    268
    Units: score
        least squares mean (standard error)
    1.23 ± 1.293
    1.37 ± 1.169
    Statistical analysis title
    		 FACIT-F statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8637
    Method
    		 Mixed models analysis
    Confidence interval

    Secondary: Change in Body Weight

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    End point title
    		 Change in Body Weight
    End point description
    Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.
    End point type
    Secondary
    End point timeframe
    Change in Body Weight from Baseline Over 12 Weeks
    End point values
    		 Placebo Anamorelin HCl
    Number of subjects analysed
    136
    268
    Units: kg
        least squares mean (standard error)
    -0.57 ± 0.438
    0.95 ± 0.386
    Statistical analysis title
    		 BW statistical analysis
    Comparison groups
    Placebo v Anamorelin HCl
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Mixed models analysis
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.
    Adverse event reporting additional description
    Adverse events that occurred following the signature of the informed consent, but prior to the first dose of study drug were not reported as adverse events in this trial. The adverse event reporting period also ended if the patient began an alternative therapy within 28 days of the last administration of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Anamorelin HCl
    Reporting group description
    		 -

    Reporting group title
    Total: Placebo and Anamorelin HCl
    Reporting group description
    		 TEAEs were defined as AEs with an onset date on or after the first dose date of the extension trial study drug and up to and including 7 days post-last dose date of the extension trial study drug.

    Serious adverse events
    		 Placebo Anamorelin HCl Total: Placebo and Anamorelin HCl
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 161 (16.77%)
    73 / 330 (22.12%)
    100 / 491 (20.37%)
         number of deaths (all causes)
    21
    48
    69
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
         subjects affected / exposed
    10 / 161 (6.21%)
    25 / 330 (7.58%)
    35 / 491 (7.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 25
    0 / 35
         deaths causally related to treatment / all
    0 / 10
    0 / 25
    0 / 35
    Gastric cancer
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiglottic carcinoma
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Hypotension
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 330 (0.91%)
    3 / 491 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
    Pyrexia
         subjects affected / exposed
    0 / 161 (0.00%)
    3 / 330 (0.91%)
    3 / 491 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 330 (0.30%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pulmonary embolism
         subjects affected / exposed
    0 / 161 (0.00%)
    4 / 330 (1.21%)
    4 / 491 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 161 (0.00%)
    5 / 330 (1.52%)
    5 / 491 (1.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 5
    0 / 5
    Pneumothorax
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 330 (0.61%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed suicide
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Confusional state
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood creatine increased
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 330 (0.30%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cardiopulmonary failure
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 330 (0.30%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    cerebrovasculary insufficiency
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 161 (1.86%)
    3 / 330 (0.91%)
    6 / 491 (1.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 161 (0.62%)
    2 / 330 (0.61%)
    3 / 491 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    2 / 161 (1.24%)
    2 / 330 (0.61%)
    4 / 491 (0.81%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Pancytopenia
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 330 (0.61%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Agranulocytosis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 330 (0.61%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 161 (0.00%)
    6 / 330 (1.82%)
    6 / 491 (1.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
    Sepsis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Tuberculosis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 161 (0.62%)
    0 / 330 (0.00%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 161 (0.62%)
    1 / 330 (0.30%)
    2 / 491 (0.41%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Hyperkalaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 161 (0.00%)
    1 / 330 (0.30%)
    1 / 491 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Anamorelin HCl Total: Placebo and Anamorelin HCl
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    72 / 161 (44.72%)
    156 / 330 (47.27%)
    228 / 491 (46.44%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm progression
         subjects affected / exposed
    0 / 161 (0.00%)
    2 / 330 (0.61%)
    2 / 491 (0.41%)
         occurrences all number
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    21 / 161 (13.04%)
    48 / 330 (14.55%)
    69 / 491 (14.05%)
         occurrences all number
    28
    61
    89
    Leukopenia
         subjects affected / exposed
    6 / 161 (3.73%)
    25 / 330 (7.58%)
    31 / 491 (6.31%)
         occurrences all number
    7
    29
    36
    Neutropenia
         subjects affected / exposed
    10 / 161 (6.21%)
    31 / 330 (9.39%)
    41 / 491 (8.35%)
         occurrences all number
    14
    48
    62
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    16 / 161 (9.94%)
    29 / 330 (8.79%)
    45 / 491 (9.16%)
         occurrences all number
    19
    30
    49
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    13 / 161 (8.07%)
    19 / 330 (5.76%)
    32 / 491 (6.52%)
         occurrences all number
    13
    20
    33
    Vomiting
         subjects affected / exposed
    9 / 161 (5.59%)
    9 / 330 (2.73%)
    18 / 491 (3.67%)
         occurrences all number
    12
    11
    23
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    7 / 161 (4.35%)
    13 / 330 (3.94%)
    20 / 491 (4.07%)
         occurrences all number
    8
    15
    23
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    14 / 161 (8.70%)
    29 / 330 (8.79%)
    43 / 491 (8.76%)
         occurrences all number
    15
    35
    50
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    3 / 161 (1.86%)
    23 / 330 (6.97%)
    26 / 491 (5.30%)
         occurrences all number
    3
    32
    35

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Apr 2012
    Protocol amendment.

    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.

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