Clinical Trial Results:
Intragastrale Injektion von Botulinum Toxin A zur Behandlung der Adipositas
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Summary
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EudraCT number |
2005-001095-13 |
Trial protocol |
AT |
Global end of trial date |
31 Mar 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
12 Feb 2022
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First version publication date |
12 Feb 2022
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
99999
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University Innsbruck
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Sponsor organisation address |
Christoph-Probst-Platz 1, Innrain 52, Innsbruck, Austria, 6020
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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
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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
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
29 Dec 2006
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Dec 2006
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Mar 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
Subjects received standard of care treatment depending on their medical history.
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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
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 10
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Worldwide total number of subjects |
10
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EEA total number of subjects |
10
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
10
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Healthy adult subjects with class I obesity, i.e. body mass index (BMI) 30-35 kg/m2, were screened. | |||||||||
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Pre-assignment
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Screening details |
All patients agreed not to undergo any weight loss treatment during the study. | |||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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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).
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Gastroenteral use
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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.
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Gastroenteral use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
BTX-A
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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
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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). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BTX-A
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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
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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). | ||
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End point title |
BMI | ||||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Day 0- Month 6
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Statistical analysis title |
BMI | ||||||||||||||||||
Comparison groups |
BTX-A v Control
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Number of subjects included in analysis |
10
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||
P-value |
= 0.12 | ||||||||||||||||||
Method |
t-test, 2-sided | ||||||||||||||||||
Confidence interval |
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Adverse events information [1]
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Timeframe for reporting adverse events |
Day 0- Month 6
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Assessment type |
Systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | |||||||||||||||
Dictionary version |
3.0
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Reporting groups
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Reporting group title |
BTX-A
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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
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Reporting group description |
- | |||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||
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| 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. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/17879570 |
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