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CompletedNCT03079557

Feasibility Pilot for the ReBOO-trial

A Non-randomised, Open Feasibility Pilot for the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' (ReBOO) Trial

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
St. Olavs Hospital · Academic / Other
Sex
All
Age
12 Years – 18 Years
Healthy volunteers
Not accepted

Summary

This is a pilot testing the feasibility of the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' trial (ReBOO-trial). The full-scale ReBOO will further investigate safety and efficacy of intragastric injections of botulinum toxin A into the antrum area of the stomach. These injections will be repeated every six months. The study sample will be adolescents with obesity who have not responded to standard conservative treatment.

Conditions

Interventions

TypeNameDescription
DRUGIntragastric botulinum toxin type A200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months

Timeline

Start date
2017-03-14
Primary completion
2019-04-30
Completion
2019-04-30
First posted
2017-03-14
Last updated
2020-09-22

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT03079557. Inclusion in this directory is not an endorsement.

Feasibility Pilot for the ReBOO-trial (NCT03079557) · Clinical Trials Directory