Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:53 AM
Study NCT ID:
NCT04682860
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002086', 'term': 'Butylscopolammonium Bromide'}], 'ancestors': [{'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-19', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Change', 'timeFrame': '30 minute and1 hour', 'description': 'Pain change after intervention at 30th and 60th minute. Pain will assesed with Visual Analog Scale (100 mm). 13 mm of change at Visual Analog Scale will assesed as clinically significant.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Gastroenteritis', 'Abdominal Pain']}, 'referencesModule': {'references': [{'pmid': '22307926', 'type': 'BACKGROUND', 'citation': 'Remington-Hobbs J, Petts G, Harris T. Emergency department management of undifferentiated abdominal pain with hyoscine butylbromide and paracetamol: a randomised control trial. Emerg Med J. 2012 Dec;29(12):989-94. doi: 10.1136/emermed-2011-200474. Epub 2012 Feb 3.'}, {'pmid': '25358721', 'type': 'BACKGROUND', 'citation': 'Arena C, Amoros JP, Vaillant V, Ambert-Balay K, Chikhi-Brachet R, Jourdan-Da Silva N, Varesi L, Arrighi J, Souty C, Blanchon T, Falchi A, Hanslik T. Acute diarrhea in adults consulting a general practitioner in France during winter: incidence, clinical characteristics, management and risk factors. BMC Infect Dis. 2014 Oct 30;14:574. doi: 10.1186/s12879-014-0574-4.'}, {'pmid': '29194529', 'type': 'BACKGROUND', 'citation': 'Shane AL, Mody RK, Crump JA, Tarr PI, Steiner TS, Kotloff K, Langley JM, Wanke C, Warren CA, Cheng AC, Cantey J, Pickering LK. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea. Clin Infect Dis. 2017 Nov 29;65(12):1963-1973. doi: 10.1093/cid/cix959.'}]}, 'descriptionModule': {'briefSummary': 'One of the most common complaints of admission to the emergency room is gastroenteritis. One of the most common complaints in acute gastroenteritis is abdominal pain. The aim of our study is to investigate whether hyoscine butylbromide used within the indication has an effect on abdominal pain due to acute gastroenteritis. The main purpose of our study is to reduce the pain of the patient at 30th and 60th minutes compared to 0th minute.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with watery stools starting in the last 2 weeks and 3 times in 24 hours and abdominal pain\n\nExclusion Criteria:\n\n* Peritonitis\n* Hemodynamic instability\n* Pregnancy\n* Inability to give consent\n* Medication given in the emergency room before being included in the study\n* Taking pain medication within 4 hours\n* Diabetes Mellitus and other neuropathic diseases'}, 'identificationModule': {'nctId': 'NCT04682860', 'briefTitle': 'Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Management of Abdominal Pain in Acute Gastroenteritis Patients With Hyoscine Butylbromide: Randomized Double Blind Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'Çağdaş Yıldırım'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'In the placebo arm, patients will be slowly injected with 2 ml of normal saline within 30 seconds', 'interventionNames': ['Other: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hyoscine N butylbromide', 'description': 'In the treatment arm, the patient will be injected intravenously with 1ml 20 mg of Hyoscine butylbromide and 1 ml of normal saline intravenously within 30 seconds.', 'interventionNames': ['Drug: Hyoscine N Butylbromide']}], 'interventions': [{'name': 'Hyoscine N Butylbromide', 'type': 'DRUG', 'description': 'Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis', 'armGroupLabels': ['Hyoscine N butylbromide']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '2 ml of normal saline injection as placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Çağdaş Yıldırım, Ass. Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara City Hospital Bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD maybe shared upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof.', 'investigatorFullName': 'Cagdas Yildirim', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}