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 : October 6, 2021
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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 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 |
Arm | Intervention/treatment |
---|---|
Experimental: Botulinum toxin A
Botulinum toxin type A injection in muscles of stomach wall
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Drug: Botulinum Toxin Type A
Other Name: Botox |
Placebo Comparator: Saline solution
Placebo (saline solution) injection first 6 months, then active treatment
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Drug: Botulinum Toxin Type A
Other Name: Botox Drug: Saline solution Other Name: NaCl |
- Body weight [ Time Frame: Change from baseline to 6 months; 1 year; 5 years ]

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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

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
Norway | |
St. Olavs Hospital, Trondheim University Hospital | |
Trondheim, Norway, 7006 |
Principal Investigator: | Bård Kulseng, MD, PhD | Norwegian University of Science and Technology, Fac MH, IKOM |
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov 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 |
botulinum toxin Endoscopy Satiation Diet Weight Loss |
Obesity Obesity, Morbid Overnutrition Nutrition Disorders Overweight Body Weight 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 |