Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 11:03 AM
Study NCT ID:
NCT03079557
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2017-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Pilot for the ReBOO-trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007065', 'term': 'Idoxuridine'}], 'ancestors': [{'id': 'D003857', 'term': 'Deoxyuridine'}, {'id': 'D014529', 'term': 'Uridine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-21', 'studyFirstSubmitDate': '2017-02-26', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BMI', 'timeFrame': '12 months', 'description': 'Proportion of participants reaching a reduction in BMI z-score equal to or more than 1'}], 'secondaryOutcomes': [{'measure': 'Injection interval', 'timeFrame': '12 months', 'description': 'Patient reports will indicate the appropriate re-injection interval'}, {'measure': 'Patient adherence to treatment', 'timeFrame': '12 months', 'description': 'Qualitative data based on interviews with patients and next of kin.'}, {'measure': 'Incidence of treatment-emergent adverse events', 'timeFrame': '2 years', 'description': 'All adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR) will be evaluated'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent', 'Injections, intraperitoneal', 'Endoscopy', 'Botulinum Toxins, Type A', 'OnabotulinumtoxinA'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "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.\n\nThe study sample will be adolescents with obesity who have not responded to standard conservative treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Written (signed) informed consent\n2. Age and gender adjusted body mass index (ISO-BMI) ≥ 35 or ISO-BMI \\> 30 with comorbidities including hypertension, non-alcoholic fatty liver disease, hyperlipidemia or impaired glucose tolerance\n3. Having partaken in a comprehensive multi-disciplinary lifestyle treatment for obesity of duration 12 months or more, without achieving a clinically significant weight loss (non-responder)\n\nExclusion Criteria:\n\n1. Known hypersensitivity to excipients in the investigational medicine product (IMP)\n2. Neuromuscular disorders\n3. History of dysphagia\n4. History of aspiration tendency or aspiration pneumonia\n5. Known lung disease under continuous treatment\n6. Congenital or acquired heart disease\n7. Previous experience of side effects to Botulinum toxin type A\n8. Present gastric diseases or dysfunction\n9. Previous bariatric surgery\n10. History of cancer\n11. Serious binge eating disorder\n12. Untreated hypothyroidism\n13. Use of aminoglycoside antibiotics or spectinomycin in the week prior to injection, or any other medicinal product that interfere with neuromuscular transmission (neuromuscular blocking agents)\n14. Medication known to affect appetite\n15. Syndromic obesity\n16. Mentally immature to a degree that there is doubt about the subject's ability to assent\n17. Issues relating to language or culture that may complicate trial participation\n18. Pregnancy or breastfeeding"}, 'identificationModule': {'nctId': 'NCT03079557', 'acronym': 'ReBOO', 'briefTitle': 'Feasibility Pilot for the ReBOO-trial', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': "A Non-randomised, Open Feasibility Pilot for the 'REpurposing BOtulinum Toxin in Treatment of Obesity in Adolescents' (ReBOO) Trial", 'orgStudyIdInfo': {'id': 'ESA 17/1878'}, 'secondaryIdInfos': [{'id': '2016-000326-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intragastric botulinum toxin type A', 'description': 'Botulinum toxin A (Allergan) injected intragastrically in the antrum', 'interventionNames': ['Drug: Intragastric botulinum toxin type A']}], 'interventions': [{'name': 'Intragastric botulinum toxin type A', 'type': 'DRUG', 'otherNames': ['Allergan'], 'description': '200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months', 'armGroupLabels': ['Intragastric botulinum toxin type A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': 'St Olavs Hospital Trondheim University Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Bård Eirik Kulseng, prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Norwegian University of Science and Technology, Fac MH, IKOM'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}