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    Clinical Trial Results:
    Extension to a multicenter, randomized, crossover, open label, dose finding study to compare the safety, efficacy and PK/PD relationship of multiple doses of SOM230 (200, 400 and 600 µg b.i.d.) and doses of open label Sandostatin (100 µg t.i.d.) in acromegalic patients

    Summary
    EudraCT number
    		 2004-002849-12
    Trial protocol
    		 GB   IT   ES  
    Global end of trial date
    06 Dec 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    17 Sep 2021
    First version publication date
    13 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Clarification added to data

    Trial information

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    Trial identification
    Sponsor protocol code
    CSOM230B2201E1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00171730
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002 , Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111 ,
    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
    06 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the long-term safety and efficacy of SOM230 in patients with acromegaly
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Aug 2004
    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
    Belgium: 4
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Australia: 2
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 10
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United States: 9
    Worldwide total number of subjects
    30
    EEA total number of subjects
    17
    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)
    27
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All Baseline data provided here was taken from the Core Study results.

    Pre-assignment
    Screening details
    		 This extension study was an open label, single arm, multi-center study in patients with acromegaly who had completed all four treatment regimens in the core study and achieved biochemical control or had clinically relevant improvement according to Investigator judgment, from at least one of the pasireotide regimens.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Pasireotide s.c. overall
    Arm description
    		 Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    pasireotide
    Investigational medicinal product code
    Other name
    SOM230
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg).

    Number of subjects in period 1
    		Pasireotide s.c. overall
    Started
    30
    Completed
    15
    Not completed
    15
         Abnormal laboratory value(s)
    1
         Consent withdrawn by subject
    3
         Adverse event, non-fatal
    3
         Unsatisfactory therapeutic effect
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pasireotide s.c. overall
    Reporting group description
    		 Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg).

    Reporting group values
    		 Pasireotide s.c. overall Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 27 27
        From 65-84 years
    		 3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.1 ( 15.48 ) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 14 14
    Subject analysis sets

    Subject analysis set title
    Pasireotide s.c. <1200 µg/d
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg). <1200 µg/day (n=30)

    Subject analysis set title
    Pasireotide s.c. 1200 to <1500 µg/d
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg). 1200 to <1500 µg/day (n=30)

    Subject analysis set title
    Pasireotide s.c. ≥1500 µg/d
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg). ≥ 1500 µg/day (n=12)

    Subject analysis sets values
    		 Pasireotide s.c. <1200 µg/d Pasireotide s.c. 1200 to <1500 µg/d Pasireotide s.c. ≥1500 µg/d
    Number of subjects
    30
    30
    11
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    27
    27
    11
        From 65-84 years
    3
    3
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    45.1 ( 15.48 )
    45.1 ( 15.48 )
    42.8 ( 12.29 )
    Gender categorical
    Units: Subjects
        Female
    16
    16
    8
        Male
    14
    14
    3

    End points

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    End points reporting groups
    Reporting group title
    Pasireotide s.c. overall
    Reporting group description
    		 Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg).

    Subject analysis set title
    Pasireotide s.c. <1200 µg/d
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg). <1200 µg/day (n=30)

    Subject analysis set title
    Pasireotide s.c. 1200 to <1500 µg/d
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg). 1200 to <1500 µg/day (n=30)

    Subject analysis set title
    Pasireotide s.c. ≥1500 µg/d
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Patients received pasireotide as a daily s.c. injection every 12 hours at 9:00 AM and 9:00 PM at the dose at which the biochemical control was achieved (either 200, 400, or 600 µg). ≥ 1500 µg/day (n=12)

    Primary: Growth hormone and IGF-1 observed response rates by dose class

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    End point title
    		 Growth hormone and IGF-1 observed response rates by dose class [1]
    End point description
    A patient was a responder to a dose level if the mean GH level after dosing (t30, t60, t90, and t120) was below/equal to 2.5µg/L, and if the mean of IGF-1 of the two predose values (t-30, t-1) was within normal limits for age-sex matched controls. If three or more of t30, t60, t90, or t120 were missing, mean GH was considered missing. If either t-30 or t-1 was missing, mean IGF-1 was considered missing.
    End point type
    Primary
    End point timeframe
    Month 3, 6 and 9
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses have been collected for this primary end point.
    End point values
    		 Pasireotide s.c. overall Pasireotide s.c. <1200 µg/d Pasireotide s.c. 1200 to <1500 µg/d Pasireotide s.c. ≥1500 µg/d
    Number of subjects analysed
    30 [2]
    30 [3]
    30 [4]
    11 [5]
    Units: percentage of responders
    number (not applicable)
        Month 3
    25
    17.6
    36.4
    0
        Month 6
    35.7
    80
    30
    0
        Month 9
    23.1
    20
    28.6
    14.3
    Notes
    [2] - n = 7, 10, 6
    [3] - n = 3, 4, 1
    [4] - n = 4, 6, 4
    [5] - n = -, 0, 1
    No statistical analyses for this end point

    Secondary: Time to tumor response

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    End point title
    		 Time to tumor response
    End point description
    Tumor response was defined as at least 20% decrease in tumor volume from baseline.
    End point type
    Secondary
    End point timeframe
    baseline to at least a 20% decrease in pituitary tumor volume
    End point values
    		 Pasireotide s.c. overall
    Number of subjects analysed
    29
    Units: months
        median (inter-quartile range (Q1-Q3))
    12.2 (4.9 to 19.2)
    No statistical analyses for this end point

    Secondary: Summary MRI pituitary tumor volumes

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    End point title
    		 Summary MRI pituitary tumor volumes
    End point description
    End point type
    Secondary
    End point timeframe
    Core study baseline till the last assessment of the extension study
    End point values
    		 Pasireotide s.c. overall
    Number of subjects analysed
    30 [6]
    Units: cubic mm
    arithmetic mean (standard deviation)
        Core study baseline
    4457.4 ( 4891.98 )
        Month 9
    2839.3 ( 2710.61 )
        Month 27
    2536 ( 2219.13 )
        Month 63
    456 ( 381.84 )
        Month 75
    1016 ( 872.39 )
        Month 99
    180 ( 0 )
    Notes
    [6] - n = 29, 16, 5, 2, 3, 1
    No statistical analyses for this end point

    Secondary: Symptoms of acromegaly

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    End point title
    		 Symptoms of acromegaly
    End point description
    Participants scored the following symptoms of acromegaly: Headache, perspiration, paresthesia, fatigue, osteoarthralgia, and carpal tunnel syndrome on a 5-point scale (0 = None/absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe).
    End point type
    Secondary
    End point timeframe
    Core study baseline till the last assessment of the extension study
    End point values
    		 Pasireotide s.c. overall
    Number of subjects analysed
    30
    Units: percentage of participants
    number (not applicable)
        Headache - 0
    46.7
        Headache - 1
    26.7
        Headache - 2
    6.7
        Headache - 3
    0
        Headache - 4
    0
        Headache - Not done
    20
        Perspiration - 0
    20
        Perspiration - 1
    33.3
        Perspiration - 2
    23.3
        Perspiration - 3
    3.3
        Perspiration - 4
    0
        Perspiration - Not done
    20
        Paresthesiae - 0
    50
        Paresthesiae - 1
    16.7
        Paresthesiae - 2
    13.3
        Paresthesiae - 3
    0
        Paresthesiae - 4
    0
        Paresthesiae - Not done
    20
        Fatigue - 0
    26.7
        Fatigue - 1
    26.7
        Fatigue - 2
    13.3
        Fatigue - 3
    13.3
        Fatigue - 4
    0
        Fatigue - Not done
    20
        Osteoarthralgia - 0
    40
        Osteoarthralgia - 1
    23.3
        Osteoarthralgia - 2
    10
        Osteoarthralgia - 3
    3.3
        Osteoarthralgia - 4
    3.3
        Osteoarthralgia - Not done
    20
        Carpal tunnel syndrome - 0
    56.7
        Carpal tunnel syndrome - 1
    10
        Carpal tunnel syndrome - 2
    10
        Carpal tunnel syndrome - 3
    3.3
        Carpal tunnel syndrome - 4
    0
        Carpal tunnel syndrome - Not done
    20
    No statistical analyses for this end point

    Secondary: Summary of Epworth Sleepiness Scale by situation (Epworth sleepiness scale)

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    End point title
    		 Summary of Epworth Sleepiness Scale by situation (Epworth sleepiness scale)
    End point description
    Sleep apnea symptoms were assessed using the Epworth Sleepiness Scale were in the categories 0 = Would never doze, 1 = Slight chance of dozing, 2 = Moderate chance of dozing, 3 = High chance of dozing.
    End point type
    Secondary
    End point timeframe
    Core study baseline till the last assessment of the extension study
    End point values
    		 Pasireotide s.c. overall
    Number of subjects analysed
    30
    Units: percentage of participants
    number (not applicable)
        Sitting and reading - 0
    36.7
        Sitting and reading - 1
    23.3
        Sitting and reading - 2
    23.3
        Sitting and reading - 3
    0
        Sitting and reading - Not done
    16.7
        Watching TV - 0
    23.3
        Watching TV - 1
    33.3
        Watching TV - 2
    23.3
        Watching TV - 3
    3.3
        Watching TV - Not done
    16.7
        Sitting, inactive in a public place - 0
    56.7
        Sitting, inactive in a public place - 1
    20
        Sitting, inactive in a public place - 2
    6.7
        Sitting, inactive in a public place - 3
    0
        Sitting, inactive in a public place - Not done
    16.7
        Passenger in a car, an hour without break - 0
    60
        Passenger in a car, an hour without break - 1
    10
        Passenger in a car, an hour without break - 2
    6.7
        Passenger in a car, an hour without break - 3
    6.7
        Passenger in a car, an hour without break - ND
    16.7
        Lying down to rest in the afternoon - 0
    13.3
        Lying down to rest in the afternoon - 1
    23.3
        Lying down to rest in the afternoon - 2
    23.3
        Lying down to rest in the afternoon - 3
    23.3
        Lying down to rest in the afternoon - Not done
    16.7
        Sitting and talking to someone - 0
    76.7
        Sitting and talking to someone - 1
    6.7
        Sitting and talking to someone - 2
    0
        Sitting and talking to someone - 3
    0
        Sitting and talking to someone - Not done
    16.7
        Sitting quietly after a lunch without alcohol - 0
    30
        Sitting quietly after a lunch without alcohol - 1
    23.3
        Sitting quietly after a lunch without alcohol - 2
    20
        Sitting quietly after a lunch without alcohol - 3
    10
        Sitting quietly after a lunch without alcohol - ND
    16.7
        In a car, stopped a few minutes in the traffic - 0
    73.3
        In a car, stopped a few minutes in the traffic - 1
    10
        In a car, stopped a few minutes in the traffic - 2
    0
        In a car, stopped a few minutes in the traffic - 3
    0
        In a car, stopped a few minutes in the traffic -ND
    16.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events are monitored from date of First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All other adverse events are monitored from First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Pasireotide s.c <1200ug/d
    Reporting group description
    		 Pasireotide s.c <1200ug/d

    Reporting group title
    Pasireotide s.c 1200-<1500ug/d
    Reporting group description
    		 Pasireotide s.c 1200-<1500ug/d

    Reporting group title
    Pasireotide s.c 1500ug/d and above
    Reporting group description
    		 Pasireotide s.c 1500ug/d and above

    Reporting group title
    Pasireotide s.c Overall
    Reporting group description
    		 Pasireotide s.c Overall

    Serious adverse events
    		 Pasireotide s.c <1200ug/d Pasireotide s.c 1200-<1500ug/d Pasireotide s.c 1500ug/d and above Pasireotide s.c Overall
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 30 (13.33%)
    2 / 12 (16.67%)
    8 / 30 (26.67%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Mucoepidermoid carcinoma
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Tracheal obstruction
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Blindness
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Acromegaly
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthropathy
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pasireotide s.c <1200ug/d Pasireotide s.c 1200-<1500ug/d Pasireotide s.c 1500ug/d and above Pasireotide s.c Overall
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 30 (70.00%)
    25 / 30 (83.33%)
    11 / 12 (91.67%)
    29 / 30 (96.67%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of liver
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    0
    0
    2
    Surgical and medical procedures
    Inguinal hernia repair
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    1
    1
    3
    Chest pain
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    1
    0
    3
    Oedema peripheral
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    1
    2
    Fatigue
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    5 / 30 (16.67%)
         occurrences all number
    3
    2
    0
    5
    Chills
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    2
    2
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    1
    2
    Psychiatric disorders
    Depression
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    3
    2
    0
    4
    Insomnia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    1
    0
    3
    Investigations
    Blood glucose increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    3 / 30 (10.00%)
         occurrences all number
    1
    1
    1
    3
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    1
    0
    2
    Blood pressure increased
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    2
    0
    4
    Injury, poisoning and procedural complications
    Incision site pain
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    0
    0
    2
    Procedural pain
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    1
    2
    Congenital, familial and genetic disorders
    Hydrocele
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 30 (6.67%)
    4 / 30 (13.33%)
    0 / 12 (0.00%)
    6 / 30 (20.00%)
         occurrences all number
    3
    4
    0
    7
    Paraesthesia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    3
    2
    0
    5
    Headache
         subjects affected / exposed
    3 / 30 (10.00%)
    4 / 30 (13.33%)
    1 / 12 (8.33%)
    7 / 30 (23.33%)
         occurrences all number
    4
    6
    2
    12
    Restless legs syndrome
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    1
    2
    Tremor
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    3 / 12 (25.00%)
    6 / 30 (20.00%)
         occurrences all number
    3
    1
    3
    7
    Pancytopenia
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    1
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    2
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 30 (6.67%)
    2 / 12 (16.67%)
    8 / 30 (26.67%)
         occurrences all number
    7
    3
    3
    13
    Flatulence
         subjects affected / exposed
    4 / 30 (13.33%)
    3 / 30 (10.00%)
    0 / 12 (0.00%)
    7 / 30 (23.33%)
         occurrences all number
    6
    3
    0
    9
    Diarrhoea
         subjects affected / exposed
    10 / 30 (33.33%)
    11 / 30 (36.67%)
    5 / 12 (41.67%)
    15 / 30 (50.00%)
         occurrences all number
    16
    17
    7
    40
    Constipation
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    1 / 12 (8.33%)
    6 / 30 (20.00%)
         occurrences all number
    3
    2
    1
    6
    Nausea
         subjects affected / exposed
    9 / 30 (30.00%)
    10 / 30 (33.33%)
    1 / 12 (8.33%)
    15 / 30 (50.00%)
         occurrences all number
    12
    13
    2
    27
    Haemorrhoids
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    0
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    0
    2
    Oesophageal spasm
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 30 (0.00%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    2
    0
    0
    2
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    4 / 30 (13.33%)
    2 / 30 (6.67%)
    1 / 12 (8.33%)
    5 / 30 (16.67%)
         occurrences all number
    4
    2
    1
    7
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    1
    2
    Alopecia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    2
    2
    0
    4
    Eczema
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    0 / 12 (0.00%)
    5 / 30 (16.67%)
         occurrences all number
    2
    5
    0
    7
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    4
    1
    0
    5
    Nephrolithiasis
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    1 / 12 (8.33%)
    3 / 30 (10.00%)
         occurrences all number
    0
    2
    1
    3
    Endocrine disorders
    Diabetes insipidus
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 30 (3.33%)
    4 / 30 (13.33%)
    0 / 12 (0.00%)
    5 / 30 (16.67%)
         occurrences all number
    1
    9
    0
    10
    Back pain
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    2 / 12 (16.67%)
    6 / 30 (20.00%)
         occurrences all number
    2
    4
    3
    9
    Arthritis
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    2
    0
    1
    3
    Jaw disorder
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Myalgia
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    0
    3
    Muscle spasms
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    1
    2
    Osteoarthritis
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    2 / 12 (16.67%)
    3 / 30 (10.00%)
         occurrences all number
    0
    1
    2
    3
    Tendonitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    4
    0
    4
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 30 (6.67%)
    2 / 12 (16.67%)
    5 / 30 (16.67%)
         occurrences all number
    3
    2
    2
    7
    Burn infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Ear infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 30 (3.33%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    0
    1
    1
    2
    Influenza
         subjects affected / exposed
    0 / 30 (0.00%)
    3 / 30 (10.00%)
    1 / 12 (8.33%)
    4 / 30 (13.33%)
         occurrences all number
    0
    5
    1
    6
    Nasopharyngitis
         subjects affected / exposed
    3 / 30 (10.00%)
    3 / 30 (10.00%)
    2 / 12 (16.67%)
    6 / 30 (20.00%)
         occurrences all number
    4
    6
    2
    12
    Otitis externa
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    2
    2
    Urinary tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    3 / 30 (10.00%)
    1 / 12 (8.33%)
    5 / 30 (16.67%)
         occurrences all number
    2
    3
    1
    6
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 30 (3.33%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    1
    1
    0
    2
    Tooth infection
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    1 / 30 (3.33%)
         occurrences all number
    0
    0
    1
    1
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    0 / 30 (0.00%)
    4 / 30 (13.33%)
    0 / 12 (0.00%)
    4 / 30 (13.33%)
         occurrences all number
    0
    5
    0
    5
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 30 (0.00%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    3
    0
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 30 (0.00%)
    1 / 12 (8.33%)
    2 / 30 (6.67%)
         occurrences all number
    1
    0
    1
    2
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 30 (6.67%)
    3 / 30 (10.00%)
    0 / 12 (0.00%)
    5 / 30 (16.67%)
         occurrences all number
    2
    3
    0
    5
    Hypoglycaemia
         subjects affected / exposed
    2 / 30 (6.67%)
    2 / 30 (6.67%)
    0 / 12 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    2
    3
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2007
    • The enrollment of patients into this extension study had closed; however, treatment of patients receiving clinical benefit was to be continued until pasireotide s.c. was commercially available or the development program was discontinued, whichever came first. As pasireotide had been well tolerated by patients with acromegaly, the visit schedule previously defined in the protocol was revised from one visit per month to one visit every three months. A 3-month interval was considered sufficient to adequately monitor safety and efficacy in this study. • Increases in blood glucose during treatment with pasireotide s.c. had been observed in previous studies. However, the increases were moderate and generally well managed by adjustment in oral hypoglycemic medications or the initiation of insulin therapy. Thus, some guidance on monitoring and the management of blood glucose levels was also added to the protocol by this amendment. • Blood samples were no longer collected for PK or biomarker development studies. • The visit schedule was amended to add urinalysis assessment, to be consistent with the assessments required by the study protocol. • In addition, editorial changes to the cover page of the protocol were made to meet regulatory requirements.
    28 Apr 2010
    Based on results obtained from the thorough QT/QTc study, which provided data on the QT/QTc intervals of a supra-therapeutic dose of pasireotide in healthy volunteers, additional ECG monitoring was implemented in ongoing pasireotide studies to further strengthen the safety of patients. Instead of recording ECGs every six months in the extension period, on implementation of the amendment, ECGs were to be recorded every three months. • In addition, the study discontinuation criteria and text on use of concomitant medications were modified to include consideration of QT measurements.
    12 Dec 2011
    • Include additional hepatic-related safety parameters as a result of an internal hepatic medical review of pasireotide study’s. Hepatic related discontinuation criteria and hepatic safety management criteria were included.
    13 Jun 2012
    Correct the assessment of laboratory samples, ECGs, and CT or MRI scan to match with the core study protocol as the extension protocol incorrectly stated local assessment. These were to be assessed centrally and results were to be transferred electronically to Novartis. • In addition clarification was provided to remove the PT (INR) collection from the blood chemistry panel. This test was only to be done if the patient meets the abnormal liver function criteria. It was not to be considered as part of routine blood chemistry panel.

    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
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    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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