NCT02035397

Intragastric Injections of Botox for the Treatment of Obesity

Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
DRUG	Botulinum Toxin Type A
DRUG	Saline solution

Timeline

• Start date: 2014-02-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2014-01-14
• Last updated: 2022-10-10

Locations

1 site across 1 country: Norway