Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
60

Inclusion Criteria

BMI > 35
BMI > 35

Exclusion Criteria

Tendency for aspiration
Previous side effects of botox injections
Hypothyroidism
...
Tendency for aspiration
Previous side effects of botox injections
Hypothyroidism
Other obesity treatment last 12 months
Pregnancy/brest feeding
Severe eating disorder
Previous cancer in GI-tract
Previous bariatric surgery
Ulcus
Neuro muscular disease
Known hypersensitivity to medication
Dysphagia
Use of aminoglycoside antibiotics and/or spectinomycin lately
Reduced competence to consent

Summary

Conditions
  • Obesity Morbid
  • Obesity, Morbid
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Inclusion Criteria

BMI > 35
BMI > 35

Exclusion Criteria

Tendency for aspiration
Previous side effects of botox injections
Hypothyroidism
...
Tendency for aspiration
Previous side effects of botox injections
Hypothyroidism
Other obesity treatment last 12 months
Pregnancy/brest feeding
Severe eating disorder
Previous cancer in GI-tract
Previous bariatric surgery
Ulcus
Neuro muscular disease
Known hypersensitivity to medication
Dysphagia
Use of aminoglycoside antibiotics and/or spectinomycin lately
Reduced competence to consent

Tracking Information

NCT #
NCT02035397
Collaborators
St. Olavs Hospital
Investigators
  • Principal Investigator: Bård Kulseng, MD, PhD Norwegian University of Science and Technology, Fac MH, IKOM
  • Bård Kulseng, MD, PhD Norwegian University of Science and Technology, Fac MH, IKOM