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Intragastric Injections of Botox for the Treatment of Obesity

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ClinicalTrials.gov Identifier: NCT02035397
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Description
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Brief Summary:

One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. If such a treatment provides a clinically significant weight loss, this could be an alternative for surgical procedures, avoiding the risk for perioperative complications as well as complications in the long run.

There are now several pilot studies documenting that intragastric treatment with botulinum toxin A (BTA) can be effective, although the treatment perspective is short and do not include repeated injections. However, they demonstrate that BTA-injections are safe for the patient. The treatment is administered by endoscopy.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Drug: Botulinum Toxin Type A Drug: Saline solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial
Actual Study Start Date : February 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulinum toxin A
Botulinum toxin type A injection in muscles of stomach wall
 Drug: Botulinum Toxin Type A
Other Name: Botox
Placebo Comparator: Saline solution
Placebo (saline solution) injection first 6 months, then active treatment
 Drug: Botulinum Toxin Type A
Other Name: Botox

Drug: Saline solution
Other Name: NaCl


Outcome Measures
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Primary Outcome Measures :
  1. Body weight [ Time Frame: Change from baseline to 6 months; 1 year; 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI > 35

Exclusion Criteria:

  • Known hypersensitivity to medication
  • Neuro muscular disease
  • Dysphagia
  • Tendency for aspiration
  • Ulcus
  • Use of aminoglycoside antibiotics and/or spectinomycin lately
  • Previous side effects of botox injections
  • Previous bariatric surgery
  • Previous cancer in GI-tract
  • Other obesity treatment last 12 months
  • Severe eating disorder
  • Hypothyroidism
  • Pregnancy/brest feeding
  • Reduced competence to consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035397


Locations
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Norway
St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Bård Kulseng, MD, PhD St. Olavs Hospital
More Information
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02035397     History of Changes
Other Study ID Numbers: 2013/1597
2012-004381-18 ( EudraCT Number )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018

Keywords provided by Norwegian University of Science and Technology:
botulinum toxin
Endoscopy
Satiation
Diet
Weight Loss

Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
 abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents