Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-25 @ 12:13 PM
Study NCT ID:
NCT03079050
Status:
COMPLETED
Last Update Posted:
2017-09-15
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064748', 'term': 'Dexlansoprazole'}], 'ancestors': [{'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'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'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-14', 'studyFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heartburn Relief', 'timeFrame': '1 month', 'description': 'The mean number of days during Ramadan with complete relief of heartburn symptoms, including nocturnal symptoms.'}], 'secondaryOutcomes': [{'measure': 'Days with partial relief of heartburn symptoms', 'timeFrame': '1 month', 'description': 'Days with partial relief of heartburn symptoms'}, {'measure': 'Days with relief of nocturnal heartburn symptoms', 'timeFrame': '1 month', 'description': 'Days with relief of nocturnal heartburn symptoms'}, {'measure': 'Improvement in sleep qualit', 'timeFrame': '1 month', 'description': 'The number of nocturnal sleeping hours will be assessed daily'}, {'measure': 'Side effects/tolerability of Dexlansoprazole 30mg vs. Dexlansoprazole 60mg', 'timeFrame': '1 month', 'description': '"Side effects and tolerability" Questionnaire'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GERD', 'Proton Pump Inhibitor']}, 'referencesModule': {'references': [{'pmid': '21780890', 'type': 'BACKGROUND', 'citation': 'Behm BW, Peura DA. Dexlansoprazole MR for the management of gastroesophageal reflux disease. Expert Rev Gastroenterol Hepatol. 2011 Aug;5(4):439-45. doi: 10.1586/egh.11.37.'}, {'pmid': '21224838', 'type': 'BACKGROUND', 'citation': 'Fass R, Johnson DA, Orr WC, Han C, Mody R, Stern KN, Pilmer BL, Perez MC. The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD. Am J Gastroenterol. 2011 Mar;106(3):421-31. doi: 10.1038/ajg.2010.458. Epub 2011 Jan 11.'}, {'pmid': '22155561', 'type': 'BACKGROUND', 'citation': "Fass R, Inadomi J, Han C, Mody R, O'Neil J, Perez MC. Maintenance of heartburn relief after step-down from twice-daily proton pump inhibitor to once-daily dexlansoprazole modified release. Clin Gastroenterol Hepatol. 2012 Mar;10(3):247-53. doi: 10.1016/j.cgh.2011.11.021. Epub 2011 Dec 7."}, {'pmid': '24632930', 'type': 'BACKGROUND', 'citation': 'Solem C, Mody R, Stephens J, Macahilig C, Gao X. Mealtime-related dosing directions for proton-pump inhibitors in gastroesophageal reflux disease: physician knowledge, patient adherence. J Am Pharm Assoc (2003). 2014 Mar-Apr;54(2):144-53. doi: 10.1331/JAPhA.2014.13117.'}, {'pmid': '18789939', 'type': 'BACKGROUND', 'citation': 'Kahrilas PJ, Shaheen NJ, Vaezi MF, Hiltz SW, Black E, Modlin IM, Johnson SP, Allen J, Brill JV; American Gastroenterological Association. American Gastroenterological Association Medical Position Statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008 Oct;135(4):1383-1391, 1391.e1-5. doi: 10.1053/j.gastro.2008.08.045. No abstract available.'}, {'pmid': '26013794', 'type': 'BACKGROUND', 'citation': 'Abbas Z. Gastrointestinal health in Ramadan with special reference to diabetes. J Pak Med Assoc. 2015 May;65(5 Suppl 1):S68-71.'}, {'pmid': '30625462', 'type': 'DERIVED', 'citation': 'Rimmani HH, Rustom LBO, Rahal MA, Shayto RH, Chaar H, Sharara AI. Dexlansoprazole is Effective in Relieving Heartburn during the Fasting Month of Ramadan. Dig Dis. 2019;37(3):188-193. doi: 10.1159/000496091. Epub 2019 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'Dexlansoprazole modified release (MR), the R-enantiomer of Lansoprazole, is an FDA approved drug (2009) for the management of erosive esophagitis and nonerosive reflux disease 1. Dexlansoprazole has a unique dual delayed-release delivery system designed to address unmet needs that may accompany traditional proton pump inhibitors, with two separate pH-depended release phases, the first in the proximal duodenum and the second in the more distal small intestine. This dual release system extends the plasma concentration and pharmacodynamics effects beyond those of single-release PPIs, allowing for dosing at any time of the day without regard to meals 1. A study conducted by Fass et al. has shown that the use of dexlansoprazole MR 30 mg in patients with symptomatic GERD is significantly more effective than placebo in improving nocturnal heartburn, reducing GERD-related sleep disturbances, and consequently improving work productivity, sleep quality and quality of life 2.\n\nBecause of its pharmacokinetic properties, Dexlansoprazole modified release (MR) may prove beneficial in optimizing the management of GERD and the associated burdens that often surface after the heavy evening and Suhur meals, such as increased nocturnal symptoms and poor sleep quality.', 'detailedDescription': 'To investigate the efficacy and quality of life improvement of Dexlansoprazole 60mg taken once daily at Iftar time in patients with known symptomatic heartburn exacerbated in Ramadan and who are not on daily treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals 18-75 years old\n* Fasting in Ramadan\n* No daily PPI use\n* Individuals willing to sign consent form\n* Patients owning a smartphone and able to use a smartphone application\n\nExclusion Criteria:\n\n* Known erosive GERD on PPI\n* Pregnant females\n* Prior gastric surgery\n* Long standing diabetes mellitus (≥10 years of disease)\n* Frequent NSAID use (\\>3x/week)\n* Morbid obesity (BMI\\>35)\n* History of recent (\\<6 months) upper GI bleeding\n* Patients who do not own a smartphone or who cannot use a smartphone application\n* Known allergy to PPIs\n* Known history of poor compliance or adherence and active psychological problems which might impact adherence'}, 'identificationModule': {'nctId': 'NCT03079050', 'briefTitle': 'An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'An Open-Label Trial of Dexlansoprazole 60mg for the Relief of Heartburn During the Fasting Month of Ramadan', 'orgStudyIdInfo': {'id': 'IM.AS1.48'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '34 patients will be assigned to take Dexlansoprazole 60mg over the 2nd, 3rd, and 4th weeks of the month of Ramadan.', 'interventionNames': ['Drug: Dexlansoprazole 60 MG']}], 'interventions': [{'name': 'Dexlansoprazole 60 MG', 'type': 'DRUG', 'otherNames': ['Dexilant 60 MG'], 'description': 'This drug will be given to 34 random patients during the 2nd, 3rd, and 4th weeks of the month of Ramadan to assess its ability to relieve GERD symptoms', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut - Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Takeda', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}