Overview

This trial is active, not recruiting.

Condition obesity, morbid
Treatments botulinum toxin type a, saline solution
Phase phase 2
Sponsor Norwegian University of Science and Technology
Collaborator St. Olavs Hospital
Start date February 2014
End date December 2022
Trial size 20 participants
Trial identifier NCT02035397, 2012-004381-18, 2013/1597

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Botulinum toxin type A injection in muscles of stomach wall
botulinum toxin type a Botox
(Placebo Comparator)
Placebo (saline solution) injection first 6 months, then active treatment
botulinum toxin type a Botox
saline solution NaCl

Primary Outcomes

Measure
Body weight
time frame: Change from baseline to 6 months; 1 year; 5 years

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Treatment of Morbid Obesity by Intragastric Injections of Botulinum Toxin A. A Randomized, Double-blind, Placebo Controlled, Phase II-trial
Principal investigator Bård Kulseng, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Norwegian University of Science and Technology.