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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000326-19 | EudraCT Number |
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intragastric botulinum toxin type A | Experimental | Botulinum toxin A (Allergan) injected intragastrically in the antrum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intragastric botulinum toxin type A | Drug | 200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months |
|
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Proportion of participants reaching a reduction in BMI z-score equal to or more than 1 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Injection interval | Patient reports will indicate the appropriate re-injection interval | 12 months |
| Patient adherence to treatment | Qualitative data based on interviews with patients and next of kin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| BÃ¥rd Eirik Kulseng, prof | Norwegian University of Science and Technology, Fac MH, IKOM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital Trondheim University Hospital | Trondheim | Norway |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007065 | Idoxuridine |
| ID | Term |
|---|---|
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| 12 months |
| Incidence of treatment-emergent adverse events | All adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) will be evaluated | 2 years |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |