Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04257851
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2020-02-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}], 'ancestors': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013806', 'term': 'Theophylline'}, {'id': 'D018170', 'term': 'Sumatriptan'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D007211', 'term': 'Indoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-31', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-05', 'lastUpdatePostDateStruct': {'date': '2021-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median and Range of Numeric Pain Rating Scale (NPRS) score [(median (range)]', 'timeFrame': '48 hours after initiation of treatment', 'description': 'NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, 18h, 24h, then every 12h till 48h)'}, {'measure': 'Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)', 'timeFrame': '48 hours after initiation of treatment', 'description': 'NPRS measures the severity of PDPH, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (before, 2h, 6h, 12h, 18h, 24h, then every 12h till 48h)'}], 'secondaryOutcomes': [{'measure': 'Mean and Standard deviation of PDPH duration (hours) (mean±SD)', 'timeFrame': '48 hours after initiation of treatment', 'description': 'Time from PDPH onset till NPRS score ≤ 3'}, {'measure': 'Mean and Standard deviation of Length of hospital stay (days) (mean±SD)', 'timeFrame': '48 hours after initiation of treatment', 'description': 'Time from hospital admission till discharge'}, {'measure': 'Number of participants and Rate of Treatment-related side effects', 'timeFrame': '48 hours after initiation of treatment', 'description': 'Number of participants and Rate of: Palpitation, Dizziness, Gastric irritation, Nausea/Vomiting, Diarrhea, Warm sensations in the body, Tingling sensation, and Tightness in the chest, throat, neck, or jaws.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post-dural puncture headache', 'Spinal anesthesia', 'Sumatriptan', 'Theophylline'], 'conditions': ['Post-Dural Puncture Headache']}, 'descriptionModule': {'briefSummary': 'Objectives: To compare the safety and efficacy of oral theophylline versus oral sumatriptan in the treatment of post-dural puncture headache (PDPH).\n\nBackground: PDPH is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia. Since invasive treatments have known complications, pharmacologic management may be preferable.\n\nPatients and Methods: This was a prospective, randomized, double-blind, phase four clinical trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly allocated into two equal groups (30 patients each); group T, received oral theophylline, and group S, received oral sumatriptan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with NPRS score of ≥ 5\n* American Society of Anesthesiologists (ASA) physical status ≤ II\n* Age from 21 to 50 years\n\nExclusion Criteria:\n\n* Patients with NPRS score \\< 5\n* ASA physical status \\> II\n* Age \\< 21 years or \\> 50 years\n* Pregnant women\n* History of; Chronic headache, Cluster headache, Migraine\n* History of; Convulsions, Cerebrovascular accident, Previous neurological diseases\n* History of peripheral vascular disease (ischemic colitis)\n* Signs of meningismus\n* Dysrhythmia\n* Hypertension\n* Ischemic heart disease\n* Hyperthyroidism\n* Liver or Renal impairment\n* Use of selective serotonin reuptake inhibitors (SSRIs)\n* Use of ergotamine derivatives in the past 24 hours\n* Use of monoamine oxidase inhibitors (MAOIs) in the last two weeks\n* Use of any kind of opiates\n* Allergy to the study medications\n* Any contraindication of oral intake'}, 'identificationModule': {'nctId': 'NCT04257851', 'briefTitle': 'Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Damanhour Teaching Hospital'}, 'officialTitle': 'Is Theophylline More Effective Than Sumatriptan in the Treatment of Post-dural Puncture Headache: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DTH: 20001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group T (n=30)', 'description': 'Theophylline group', 'interventionNames': ['Drug: Theophylline Anhydrous Oral Tablet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group S (n=30)', 'description': 'Sumatriptan group', 'interventionNames': ['Drug: Sumatriptan Succinate Oral Tablet']}], 'interventions': [{'name': 'Theophylline Anhydrous Oral Tablet', 'type': 'DRUG', 'otherNames': ['Quibron-T/SR tablets'], 'description': 'Theophylline tablet (150 mg/12h)', 'armGroupLabels': ['Group T (n=30)']}, {'name': 'Sumatriptan Succinate Oral Tablet', 'type': 'DRUG', 'otherNames': ['Sumigran tablets'], 'description': 'Sumatriptan tablet (25 mg/12h)', 'armGroupLabels': ['Group S (n=30)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Damanhūr', 'state': 'El-Beheira', 'country': 'Egypt', 'facility': 'Damanhour Teaching Hospital', 'geoPoint': {'lat': 27.38333, 'lon': 30.95}}], 'overallOfficials': [{'name': 'Ahmed M Shaat, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Damanhour Teaching Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Damanhour Teaching Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}