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    Clinical Trial Results:
    Multicentre, controlled, randomised, open-label, cross-over clinical study of the efficacy and tolerability of L-thyroxine T4 soft capsules, in comparison to L-thyroxine tablets, in thyroidectomised patients.

    Summary
    EudraCT number
    		 2006-002614-36
    Trial protocol
    		 IT   FR  
    Global end of trial date
    25 Feb 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Nov 2021
    First version publication date
    12 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    05ICHF/T407
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IBSA
    Sponsor organisation address
    Via del Piano, Pambio-Noranco, Switzerland, 6915
    Public contact
    Giuseppe Mautone, IBSA, sd@ibsa.ch
    Scientific contact
    Giuseppe Mautone, IBSA, sd@ibsa.ch
    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
    23 Sep 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Feb 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study is to compare the therapeutic activity of L-thyroxine in soft capsule formulation for oral use with L-thyroxine in a tablet formulation.
    Protection of trial subjects
    Patients were followed up according to the standard of care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 May 2007
    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
    France: 8
    Country: Number of subjects enrolled
    Italy: 179
    Country: Number of subjects enrolled
    Switzerland: 18
    Worldwide total number of subjects
    205
    EEA total number of subjects
    187
    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)
    182
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was done between April 2007 and February 2009 in all countries

    Pre-assignment
    Screening details
    		 236 subjects were screened on the basis of medical history and findings in the physical examination and laboratory investigations. 31 subjects failed screening for: noncompliance with inclusion/exclusion criteria, need for LT4 dose adjustment, not allowed therapy, voluntary withdrawal

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LT4 soft capsule
    Arm description
    		 daily treatment with LT4 soft capsules at the same dose as the subject was treated before
    Arm type
    		 Experimental

    Investigational medicinal product name
    L-thyroxine, soft capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was variable and customised for each patient. Dose should have been kept constant throughout the duration of the study, with an initial dose being the same as that previously being taken before the study start, but changes within ±35% of the dose previously taken were allowed.

    Arm title
    		 LT4 tablet
    Arm description
    		 daily treatment with LT4 tablet at the same dose as the subject was treated before
    Arm type
    		 Active comparator

    Investigational medicinal product name
    L-thyroxine, tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was variable and customised for each patient. Dose should have been kept constant throughout the duration of the study, with an initial dose being the same as that previously being taken before the study start, but changes within ±35% of the dose previously taken were allowed

    Number of subjects in period 1
    		LT4 soft capsule LT4 tablet
    Started
    98
    107
    V2
    97
    104
    Completed
    95
    102
    Not completed
    3
    5
         exclusion criterion
    1
    -
         Consent withdrawn by subject
    -
    3
         Adverse event, non-fatal
    -
    1
         Lost to follow-up
    2
    1
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LT4 soft capsule
    Arm description
    		 daily treatment with LT4 soft capsules at the same dose as the subject was treated before
    Arm type
    		 Experimental

    Investigational medicinal product name
    L-thyroxine, soft capsules
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was variable and customised for each patient. Dose should have been kept constant throughout the duration of the study, with an initial dose being the same as that previously being taken before the study start, but changes within ±35% of the dose previously taken were allowed.

    Arm title
    		 LT4 tablets
    Arm description
    		 daily treatment with LT4 tablets at the same dose as the subject was treated before
    Arm type
    		 Active comparator

    Investigational medicinal product name
    L-thyroxine, tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dose was variable and customised for each patient. Dose should have been kept constant throughout the duration of the study, with an initial dose being the same as that previously being taken before the study start, but changes within ±35% of the dose previously taken were allowed

    Number of subjects in period 2
    		LT4 soft capsule LT4 tablets
    Started
    102
    95
    V4
    99
    94
    Completed
    98
    93
    Not completed
    4
    2
         Consent withdrawn by subject
    3
    -
         Adverse event, non-fatal
    1
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 all enrolled subjects

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 205 205
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 182 182
        From 65-84 years
    		 23 23
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.56 ± 12.24 -
    Gender categorical
    Units: Subjects
        Female
    		 152 152
        Male
    		 53 53
    Subject analysis sets

    Subject analysis set title
    LT4 soft capsules
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomised patients who received at least one dose of both the test and the reference treatment, analysed for the cross-over period with LT4 soft capsules

    Subject analysis set title
    LT4 tablets
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomised patients who received at least one dose of both the test and the reference treatment, analysed for the cross-over period with LT4 tablets

    Subject analysis sets values
    		 LT4 soft capsules LT4 tablets
    Number of subjects
    205
    205
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    182
    182
        From 65-84 years
    23
    23
        85 years and over
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.56 ± 12.24
    50.56 ± 12.24
    Gender categorical
    Units: Subjects
        Female
    152
    152
        Male
    53
    53

    End points

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    End points reporting groups
    Reporting group title
    LT4 soft capsule
    Reporting group description
    		 daily treatment with LT4 soft capsules at the same dose as the subject was treated before

    Reporting group title
    LT4 tablet
    Reporting group description
    		 daily treatment with LT4 tablet at the same dose as the subject was treated before
    Reporting group title
    LT4 soft capsule
    Reporting group description
    		 daily treatment with LT4 soft capsules at the same dose as the subject was treated before

    Reporting group title
    LT4 tablets
    Reporting group description
    		 daily treatment with LT4 tablets at the same dose as the subject was treated before

    Subject analysis set title
    LT4 soft capsules
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomised patients who received at least one dose of both the test and the reference treatment, analysed for the cross-over period with LT4 soft capsules

    Subject analysis set title
    LT4 tablets
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    all randomised patients who received at least one dose of both the test and the reference treatment, analysed for the cross-over period with LT4 tablets

    Primary: FT4-6 month

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    End point title
    		 FT4-6 month
    End point description
    difference of serum levels of FT4 between start and end of a 6-month treatment period, analysed according to cross over design (equivalence bounds: +/- 2.57 pmol/L)
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    		 LT4 soft capsule LT4 soft capsule LT4 tablet LT4 tablets LT4 soft capsules LT4 tablets
    Number of subjects analysed
    91
    92
    92
    91
    183
    183
    Units: pmol/L
        arithmetic mean (standard deviation)
    -0.46 ± 2.53
    -0.81 ± 2.84
    -0.64 ± 2.03
    0.48 ± 2.41
    -0.64 ± 2.69
    -0.08 ± 2.29
    Statistical analysis title
    		 ANCOVA-FT4-6 months
    Statistical analysis description
    analysis of cavariance for cross-over design
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0786 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06403
         upper limit
    		 1.173051
    Notes
    [1] - the 95% confidence interval for the mean difference between the groups ranges from -0.06403 to 1.173051 and is well within the equivalence margins ±2.57

    Secondary: FT3-6 month

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    End point title
    		 FT3-6 month
    End point description
    difference between the serum levels of FT3 at start and end of the two treatment periods, analysed according to a crossover design
    End point type
    Secondary
    End point timeframe
    6 month
    End point values
    		 LT4 soft capsule LT4 soft capsule LT4 tablet LT4 tablets LT4 soft capsules LT4 tablets
    Number of subjects analysed
    91
    92
    92
    91
    183
    183
    Units: pmol/L
        arithmetic mean (standard deviation)
    -0.04 ± 0.43
    -0.15 ± 0.45
    -0.00 ± 0.37
    -0.00 ± 0.43
    -0.09 ± 0.44
    -0.00 ± 0.40
    Statistical analysis title
    		 ANCOVA-FT3-6 months
    Statistical analysis description
    analysis of covariance for cross-over design
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1067
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.088855
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.196987
         upper limit
    		 0.019277

    Secondary: TSH-6 months

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    End point title
    		 TSH-6 months
    End point description
    difference between the serum levels of TSH at start and end of the two treatment periods, analysed according to a crossover design
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 LT4 soft capsule LT4 soft capsule LT4 tablet LT4 tablets LT4 soft capsules LT4 tablets
    Number of subjects analysed
    91
    92
    92
    91
    183
    183
    Units: mU/L
        arithmetic mean (standard deviation)
    0.204 ± 0.951
    0.501 ± 3.013
    0.322 ± 1.193
    -0.211 ± 1.112
    0.353 ± 2.238
    0.057 ± 1.181
    Statistical analysis title
    		 ANCOVA-TSH-6 months
    Statistical analysis description
    analysis of covariance for cross-over design
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    366
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.1736
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.296553
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.724849
         upper limit
    		 0.131744

    Secondary: dose-6 months

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    End point title
    		 dose-6 months
    End point description
    daily T4 dose at the end of each treatment period
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 LT4 soft capsules LT4 tablets
    Number of subjects analysed
    193
    196
    Units: mcg
        arithmetic mean (standard deviation)
    132.22 ± 32.60
    131.31 ± 31.90
    Statistical analysis title
    		 ANOVA-dose-6 months
    Statistical analysis description
    analysis of variance
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.4945
    Method
    		 ANOVA
    Confidence interval

    Secondary: dose changes

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    End point title
    		 dose changes
    End point description
    number of subjects experiencing dose changes
    End point type
    Secondary
    End point timeframe
    throughout the treatment period
    End point values
    		 LT4 soft capsules LT4 tablets
    Number of subjects analysed
    193
    197
    Units: subjects
    48
    39
    Statistical analysis title
    		 Chi square-dose changes
    Statistical analysis description
    chi square test on the number of subjects requiring changes in T4 daily dose during each treatment period
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    390
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.2289
    Method
    		 Chi-squared
    Confidence interval

    Secondary: metabolic control-hypothyroidism-6 month

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    End point title
    		 metabolic control-hypothyroidism-6 month
    End point description
    frequency of subjects displaying signs/symptoms of hypothyroidism at the end of the tretament period
    End point type
    Secondary
    End point timeframe
    6 month
    End point values
    		 LT4 soft capsules LT4 tablets
    Number of subjects analysed
    193
    195
    Units: subjects
    0
    0
    Statistical analysis title
    		 Chi square-hypothyroidism
    Statistical analysis description
    Chi square test on the number of subjects with signs/symptoms of hypothyroidism at the end of the treatment period
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 1 [2]
    Method
    		 Chi-squared
    Confidence interval
    Notes
    [2] - p value cannot be calculated because the result is 0 in both groups

    Secondary: metabolic control-hyperthyrodism-6 month

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    End point title
    		 metabolic control-hyperthyrodism-6 month
    End point description
    frequency of subjects displaying signs/symptoms of hyperthyroidism at the end of the tretament period
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 LT4 soft capsules LT4 tablets
    Number of subjects analysed
    193
    195
    Units: subjects
    1
    2
    Statistical analysis title
    		 Chi square-hyperthyroidism
    Statistical analysis description
    Chi-square test on the number of subjects displying signs/symptoms of hyperthyroidism at the end of the treatment period
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    388
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5682
    Method
    		 Chi-squared
    Confidence interval

    Secondary: patient satisfaction-6 month

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    End point title
    		 patient satisfaction-6 month
    End point description
    patient satisfaction scored by subjects at the end of the treatment period
    End point type
    Secondary
    End point timeframe
    6 months
    End point values
    		 LT4 soft capsules LT4 tablets
    Number of subjects analysed
    193
    196
    Units: subjects
        fair
    2
    2
        good
    130
    158
        very good
    61
    36
    Statistical analysis title
    		 Chi square-patient satisfaction
    Statistical analysis description
    Mantel-Haenszel Chi square for trend test on patient satisfaction evaluated at the end of the treatments cycles
    Comparison groups
    LT4 soft capsules v LT4 tablets
    Number of subjects included in analysis
    389
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.0038
    Method
    		 Mantel-Haenszel
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    whole study duration, from screening to final visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    LT4 soft capsule
    Reporting group description
    		 daily treatment with LT4 soft capsules at the same dose as the subject was treated before

    Reporting group title
    LT4 tablet
    Reporting group description
    		 daily treatment with LT4 tablet at the same dose as the subject was treated before

    Serious adverse events
    		 LT4 soft capsule LT4 tablet
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 205 (0.49%)
    3 / 205 (1.46%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Multiple fractures
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 205 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine fibrosis
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 LT4 soft capsule LT4 tablet
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 205 (3.90%)
    13 / 205 (6.34%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Vascular disorders
    Thrombophlebitis
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Myomectomy
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 205 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 205 (0.98%)
    0 / 205 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Uterine fibrosis
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Metrorrhagia
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dry throat
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 205 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 205 (0.00%)
    2 / 205 (0.98%)
         occurrences all number
    0
    2
    Sleep disorder
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Investigations
    Weight increased
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Foot fracture
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 205 (0.00%)
         occurrences all number
    1
    0
    Multiple fractures
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    2 / 205 (0.98%)
    4 / 205 (1.95%)
         occurrences all number
    2
    4
    Atrial fibrillation
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 205 (0.00%)
         occurrences all number
    1
    0
    Cardiac failure
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 205 (0.49%)
    0 / 205 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 205 (0.00%)
    1 / 205 (0.49%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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
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    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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