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Feasibility Pilot for the ReBOO-trial

NCT03079557 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-09-22

No results posted yet for this study

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

DRUG

Intragastric botulinum toxin type A

200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months

Sponsors & Collaborators

  • Norwegian University of Science and Technology

    collaborator OTHER

  • St. Olavs Hospital

    lead OTHER

Principal Investigators

  • Bård Eirik Kulseng, prof · Norwegian University of Science and Technology, Fac MH, IKOM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-14
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03079557 on ClinicalTrials.gov