Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-26 @ 8:48 AM
Study NCT ID:
NCT01148303
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2010-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D005215', 'term': 'Fasting'}], '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': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-07', 'studyFirstSubmitDate': '2010-06-17', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2011-03-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache', 'timeFrame': 'Two weeks', 'description': "The subjects will be asked to fill out a daily 'headache diary' at the end of the fast. They will be asked if they had a headache on that day, and if so its severity. We will then compare the number of subjects having a headache on each day and total number of 'headache days' between the groups."}], 'secondaryOutcomes': [{'measure': 'Severity of Headache', 'timeFrame': 'Two weeks', 'description': 'We will ask the subject if they had a headache on a given day to rate its severity. We will then compare the severity of headache between groups.'}, {'measure': 'Overall ease of fast', 'timeFrame': 'Two weeks', 'description': 'We will ask subjects to rate the ease of their fast on a daily basis on a 5 point scale and will compare general ease of fast between the groups.'}, {'measure': 'Side effects and other symptoms', 'timeFrame': 'two weeks', 'description': 'We will ask subjects to record other symptoms or side effects they had during the fast including nausea, abdominal pain, photophobia, difficulty breathing or other.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Headache', 'Fasting', 'Fasting Headache', 'Ramadan', 'Ramadan Headache', 'Yom Kippur', 'Yom Kippur Headache'], 'conditions': ['Headache', 'Fasting', 'Fasting Headache', 'Ramadan Headache']}, 'referencesModule': {'references': [{'pmid': '17115981', 'type': 'BACKGROUND', 'citation': 'Drescher MJ, Elstein Y. Prophylactic COX 2 inhibitor: an end to the Yom Kippur headache. Headache. 2006 Nov-Dec;46(10):1487-91. doi: 10.1111/j.1526-4610.2006.00609.x.'}, {'pmid': '20039959', 'type': 'BACKGROUND', 'citation': 'Drescher MJ, Alpert EA, Zalut T, Torgovicky R, Wimpfheimer Z. Prophylactic etoricoxib is effective in preventing Yom Kippur headache: a placebo-controlled double-blind and randomized trial of prophylaxis for ritual fasting headache. Headache. 2010 Sep;50(8):1328-34. doi: 10.1111/j.1526-4610.2009.01587.x. Epub 2009 Dec 21.'}, {'pmid': '16033610', 'type': 'BACKGROUND', 'citation': 'Topacoglu H, Karcioglu O, Yuruktumen A, Kiran S, Cimrin AH, Ozucelik DN, Sarikaya S, Soysal S, Turpcu U, Bozkurt S. Impact of Ramadan on demographics and frequencies of disease-related visits in the emergency department. Int J Clin Pract. 2005 Aug;59(8):900-5. doi: 10.1111/j.1742-1241.2005.00460.x.'}, {'pmid': '11279933', 'type': 'BACKGROUND', 'citation': 'Awada A, al Jumah M. The first-of-Ramadan headache. Headache. 1999 Jul-Aug;39(7):490-3. doi: 10.1046/j.1526-4610.1999.3907490.x.'}, {'pmid': '10862316', 'type': 'BACKGROUND', 'citation': 'Shah PA, Nafee A. Clinical profile of headache and cranial neuralgias. J Assoc Physicians India. 1999 Nov;47(11):1072-5.'}, {'pmid': '21848948', 'type': 'DERIVED', 'citation': 'Drescher MJ, Wimpfheimer Z, Abu Khalef S, Gammaitoni A, Shehadeh N, Torgovicky R. Prophylactic etoricoxib is effective in preventing "first of Ramadan" headache: a placebo-controlled double-blind and randomized trial of prophylactic etoricoxib for ritual fasting headache. Headache. 2012 Apr;52(4):573-81. doi: 10.1111/j.1526-4610.2011.01993.x. Epub 2011 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'The investigators intend to study whether the use of the pain medication etoricoxib (Arcoxia) taken just before the Ramadan fast will prevent or lessen headache that some people get while fasting. The investigators hypothesize that etoricoxib will reduce the number of people getting headache, more than placebo. The investigators will do this by giving participants in the study either real medication or placebo (sugar pill) and comparing the results. The investigators will study this over two weeks. The first week one group will get the medicine and the other the placebo. The second the groups will switch. Neither the subjects nor the investigators will know who is in which group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 -65.\n* Patients will be enrolled if they declared that they intended to complete the dawn to dusk Ramadan fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)\n* Patient states that he/she typically suffered from headache during fasting in the past.\n\nExclusion Criteria:\n\n* Patients with a history of severe cardiovascular disease, diabetes, asthma, COPD, hypertension, or a history of bleeding, particularly in the gastrointestinal tract\n* Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors\n* Pregnant or lactating patients. Sexually active women of childbearing age will be included only if using birth control\n* Severe hepatic dysfunction\n* Estimated renal creatinine clearance \\<30 ml/min\n* History of peptic ulcer, erosive gastritis, esophagitis or inflammatory bowel disease\n* Congestive heart failure\n* Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled Established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease\n* Cancer or any other malignant disease\n* History of medication overuse. Overuse of analgesics or antimigraine drugs according to the IHS criteria (chapter 8)'}, 'identificationModule': {'nctId': 'NCT01148303', 'briefTitle': 'Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache', 'organization': {'class': 'OTHER', 'fullName': 'Hartford Hospital'}, 'officialTitle': 'Randomized, Placebo Controlled Trial of Etoricoxib (Arcoxia) Taken Prophylactically to Prevent Ramadan Headache', 'orgStudyIdInfo': {'id': 'ARX_ISP_IL1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etoricoxib First', 'description': 'This arm will receive etoricoxib for six days, followed by placebo for eight days.', 'interventionNames': ['Drug: Etoricoxib', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Etoricoxib Second', 'description': 'This arm will get placebo for eight days before beginning their fast, followed by etoricoxib for six days.', 'interventionNames': ['Drug: Etoricoxib', 'Drug: Placebo']}], 'interventions': [{'name': 'Etoricoxib', 'type': 'DRUG', 'otherNames': ['arcoxia'], 'description': 'Subjects will take etoricoxib 90mg by mouth just before the start of the daily fast. This will be for six days. After this they will receive placebo for eight days.', 'armGroupLabels': ['Etoricoxib First']}, {'name': 'Etoricoxib', 'type': 'DRUG', 'otherNames': ['Arcoxia'], 'description': 'This arm will receive placebo just before their fast for eight days. After this they will receive etoricoxib 90mg just before their daily fast for the next six days.', 'armGroupLabels': ['Etoricoxib Second']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Etoricoxib First', 'Etoricoxib Second']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Naim Shehadeh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}, {'name': 'Zev Wimpfheimer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hartford Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Michael J Drescher MD', 'oldOrganization': 'Hartford Hospital'}}}}