Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT01499693
Status:
WITHDRAWN
Last Update Posted:
2012-09-17
First Post:
2011-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-14', 'studyFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2011-12-23', 'lastUpdatePostDateStruct': {'date': '2012-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Percentage of time with intragastric pH above 4.0, measured by continuous 24 hour intragastric pH-Metry.', 'timeFrame': 'Three 24-hour measurements will be performed: on day 0 (baseline) and on day 6 of each treatment period.', 'description': 'Electrode will be placed in the gastric lumen, 10 cm below the lower esophageal sphincter. The percentage of time with pH \\>4.0 between both treatments will be compared.'}], 'secondaryOutcomes': [{'measure': 'Vital signs, physical exploration and common laboratory tests (if required).', 'timeFrame': 'Day 0 (baseline) and day 6 of each treatment period.', 'description': 'Safety will be established by monitoring these clinical criteria'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Proton Pump Inhibitors', 'gastric pH'], 'conditions': ['Gastric pH Control']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if magnesium pantoprazole 20 mg twice a day (b.i.d.), maintains gastric pH above 4 during a longer percentage of time than magnesium pantoprazole 40 mg once a day (qd). This is a comparison between split dose concept and standard dose of proton pump inhibitors.', 'detailedDescription': 'Eligible healthy volunteers will be randomly assigned for 2 different treatment sequences: A) magnesium pantoprazole 20 mg b.i.d. followed by magnesium pantoprazole 40 mg q.d. or B) magnesium pantoprazole 40 mg q.d. followed by magnesium pantoprazole 20 mg b.i.d.\n\nTreatment sequences will be administrated as follows: 6 days with the first medication, followed by a washout period of 8 days (no medication) and a further period of 6 days with the second medication.\n\nTreatment efficacy will be established by the percentage of time with intragastric pH \\>4, measured by 24-hour pH-Metry on day 6 of each medication (on-treatment measurement). Basal pH will be measured as reference.\n\nThe blinding distribution of treatments will be maintained for the patients, the doctor and the statistician who will analyze the data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Main inclusion criteria:\n\n* Carlsson-Dent Questionnaire with score ≤ 4 (negative for GERD).\n* Endoscopy: negative for GERD\n* BMI between 18.5 and 30\n\nMain exclusion criteria:\n\n* Volunteers with any the following symptoms: dysphagia, digestive track bleeding, anorexia, anemia, involuntary weight loss.\n* Women under breastfeeding period, pregnant or under pregnancy suspicion.\n* Subjects with abnormal manometry (any motor esophageal disorder).\n* Peptic ulcer history and/or ulcer complication.\n* Volunteers under PPI treatment, H. pylori eradication treatment, H2 receptor antagonists, prokinetics or similar medication (current, during the last 30 days or during the trial).\n* History of systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAID) use, during the last 30 days.\n* Abnormal laboratory parameters or vital signs, considered clinically relevant by the researcher.'}, 'identificationModule': {'nctId': 'NCT01499693', 'briefTitle': 'Magnesium Pantoprazole 20mg b.i.d. vs Magnesium Pantoprazole 40mg q.d. on Intragastric Acid Inhibition', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Phase IIIb, Randomized, Triple-blinded and Crossover Study to Evaluate the Effect of Magnesium Pantoprazole 20mg Bid Versus Magnesium Pantoprazole 40mg qd on Intragastric Acid Inhibition Assessed by pHmetry, in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'MX026'}, 'secondaryIdInfos': [{'id': 'U1111-1132-3320', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium Pantoprazole 20mg', 'interventionNames': ['Drug: Magnesium Pantoprazole 20 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Magnesium Pantoprazole 40mg', 'interventionNames': ['Drug: Magnesium Pantoprazole 40 mg', 'Drug: Placebo']}], 'interventions': [{'name': 'Magnesium Pantoprazole 20 mg', 'type': 'DRUG', 'otherNames': ['Tecta 20'], 'description': 'oral dose, twice a day', 'armGroupLabels': ['Magnesium Pantoprazole 20mg']}, {'name': 'Magnesium Pantoprazole 40 mg', 'type': 'DRUG', 'otherNames': ['Tecta 40'], 'description': 'oral dose, once a day (morning)', 'armGroupLabels': ['Magnesium Pantoprazole 40mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral dose, once a day (night)\n\nPlacebo will be administered at night in the group with 40mg magnesium pantoprazole to keep the blinding (so treatment administration is comparable w/the 20mg group).', 'armGroupLabels': ['Magnesium Pantoprazole 40mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11850', 'city': 'Mexico City', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Hospital Español de Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Edgardo Suarez, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinic at Hospital Español de Mexico'}, {'name': 'Jose A Vargas, MD, MSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}