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Intragastric Injections of Botox for the Treatment of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02035397
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : October 6, 2021
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

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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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT02035397

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St. Olavs Hospital, Trondheim University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
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Principal Investigator: Bård Kulseng, MD, PhD Norwegian University of Science and Technology, Fac MH, IKOM
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Responsible Party: Norwegian University of Science and Technology Identifier: NCT02035397    
Other Study ID Numbers: 2013/1597
2012-004381-18 ( EudraCT Number )
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Keywords provided by Norwegian University of Science and Technology:
botulinum toxin
Weight Loss
Additional relevant MeSH terms:
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Obesity, Morbid
Nutrition Disorders
Body Weight
Botulinum Toxins
Botulinum Toxins, Type A
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