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    Clinical Trial Results:
    Intragastrale Injektion von Botulinum Toxin A zur Behandlung der Adipositas

    Summary
    EudraCT number
    		 2005-001095-13
    Trial protocol
    		 AT  
    Global end of trial date
    31 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2022
    First version publication date
    12 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    99999
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University Innsbruck
    Sponsor organisation address
    Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
    Public contact
    Prim. Univ.-Prof. Dr. Reinhard Mittermair, Klinikum Klagenfurt, Abteilung für Allgemein- und Viszeralchirurgie, Feschnigstrasse 11, 9020 K, +43 (0)46353831403, Reinhard.Mittermair@kabeg.at
    Scientific contact
    Prim. Univ.-Prof. Dr. Reinhard Mittermair, Klinikum Klagenfurt, Abteilung für Allgemein- und Viszeralchirurgie, Feschnigstrasse 11, 9020 K, +43 (0)46353831403, Reinhard.Mittermair@kabeg.at
    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
    29 Dec 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Dec 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Hypothetically, BTX-A should inhibit the acetylcholine-mediated peristalsis, which is mainly responsible for gastric motility, and thereby induce slowed gastric emptying, earlier satiety and weight loss. The aim of this study was to observe the effects of endoscopic intragastric injections of BTX-A in obese patients.
    Protection of trial subjects
    Subjects received standard of care treatment depending on their medical history.
    Background therapy
    		 -
    Evidence for comparator
    		 Subjects with class I obesity (body mass index 30-35) were double-blind randomized into 2 groups (BTX-A and 0.9% Saline).
    Actual start date of recruitment
    13 Jun 2005
    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
    Austria: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy adult subjects with class I obesity, i.e. body mass index (BMI) 30-35 kg/m2, were screened.

    Pre-assignment
    Screening details
    		 All patients agreed not to undergo any weight loss treatment during the study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Patients with class I obesity (body mass index 30-35) were double-blind randomized into 2 groups (BTX-A and 0.9% Saline).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BTX-A
    Arm description
    		 Group 1 (BTX-A): endoscopic injection of 200U BTX-A into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Botox
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    BTX-A (Botox ®, Allergan, Irvine, CA, USA) – with 100 U of botulinum toxin A – was reconstructed in 0.9% sodium chloride. Two BTX-A were used and each reconstituted in 8 ml 0.9% sodium chloride (200 U BTX-A in 16 ml diluent). The volume of the diluent used corresponded to the number of puncture sites (16 times). Thus, 1 ml of BTX-A solution was injected at each puncture site. Puncture of the gastric wall was performed in a circular manner, with four punctures in each of four circles: The four circles were located 4, 6, 8 and 12 cm cranial to the pylorus. BTX-A was injected into the gastric wall using a standard 5-mm protruding sclerotherapy needle. The sclerotherapy needle was introduced deeply into the gastric wall, and the BTX-A solution was slowly injected. At the last puncture site, saline was injected through the needle to push out the BTX-A solution remaining in the lumen.

    Arm title
    		 Control
    Arm description
    		 Group 2 (control): endoscopic injection of 0.9% sodium chloride into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).
    Arm type
    		 Placebo

    Investigational medicinal product name
    0.9% Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    The volume of the solution (16 mL 0.9% sodium chloride) corresponded to the number of puncture sites (16 times). Thus, 1 ml of 0.9% sodium chloride solution was injected at each puncture site. Puncture of the gastric wall was performed in a circular manner, with four punctures in each of four circles: The four circles were located 4, 6, 8 and 12 cm cranial to the pylorus. 0.9% sodium chloride was injected into the gastric wall using a standard 5-mm protruding sclerotherapy needle. The sclerotherapy needle was introduced deeply into the gastric wall, and the 0.9% sodium chloride solution was slowly injected. At the last puncture site, saline was injected through the needle to push out the 0.9% sodium chloride solution remaining in the lumen.

    Number of subjects in period 1
    		BTX-A Control
    Started
    5
    5
    Completed
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BTX-A
    Reporting group description
    		 Group 1 (BTX-A): endoscopic injection of 200U BTX-A into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).

    Reporting group title
    Control
    Reporting group description
    		 Group 2 (control): endoscopic injection of 0.9% sodium chloride into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).

    Reporting group values
    		 BTX-A Control Total
    Number of subjects
    		 5 5 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 5 10
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 31.6 (20 to 39) 28.4 (21 to 35) -
    Gender categorical
    Units: Subjects
        Female
    		 5 5 10
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    BTX-A
    Reporting group description
    		 Group 1 (BTX-A): endoscopic injection of 200U BTX-A into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).

    Reporting group title
    Control
    Reporting group description
    		 Group 2 (control): endoscopic injection of 0.9% sodium chloride into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).

    Primary: BMI

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    End point title
    		 BMI
    End point description
    End point type
    Primary
    End point timeframe
    Day 0- Month 6
    End point values
    		 BTX-A Control
    Number of subjects analysed
    5
    5
    Units: kg/m2
    median (full range (min-max))
        Day 0
    32.4 (31.1 to 34.0)
    32.6 (31.5 to 33.5)
        Month 6
    32.5 (31.1 to 34.7)
    32.6 (31.1 to 34.2)
    Statistical analysis title
    		 BMI
    Comparison groups
    BTX-A v Control
    Number of subjects included in analysis
    10
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 0- Month 6
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3.0
    Reporting groups
    Reporting group title
    BTX-A
    Reporting group description
    		 Group 1 (BTX-A): endoscopic injection of 200U BTX-A into the antrum and distal gastric body. Body weight and height were measured, and BMI was calculated immediately before the endoscopic injection. After treatment, weight and BMI were determined monthly until the end of the study (6 months).

    Reporting group title
    Control
    Reporting group description
    		 -

    Serious adverse events
    		 BTX-A Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BTX-A Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 5 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No non-serious adverse events or serious adverse events were observed during the trial.

    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 reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/17879570
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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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