Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2026-03-15 @ 4:40 AM
Study NCT ID:
NCT02091635
Status:
COMPLETED
Last Update Posted:
2014-03-19
First Post:
2014-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'C533973', 'term': 'DA-9701'}], 'ancestors': [{'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-18', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2014-03-18', 'lastUpdatePostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total gastric volume (TGV) after the test meal', 'timeFrame': 'This outcome is measured on day 7 after 5days of treatment. The change is defined as difference between TGV 15min after the test meal and at the pre-test meal.'}], 'secondaryOutcomes': [{'measure': 'Gastric emptying (GE) rate', 'timeFrame': 'This outcome is measured on day 7 after 5 days of treatment'}, {'measure': 'Change in proximal TGV after the test meal', 'timeFrame': 'This outcome is mesured on day 7 after 5 days of treatment. The change is defined as difference between proximal TGV 15 min after the test meal and at the pre-test meal.'}, {'measure': 'Change in proximal to distal TGV ratio after the test meal', 'timeFrame': 'This outcome is measured on day 7 after 5 days of treatment. The change is defined as difference between proximal to distal TGV ratio 15 min after the test meal and at the pre-test meal.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['accommodation, emptying, motilitone'], 'conditions': ['Dyspepsia']}, 'referencesModule': {'references': [{'pmid': '26402448', 'type': 'DERIVED', 'citation': 'Min YW, Min BH, Kim S, Choi D, Rhee PL. Effect of DA-9701 on Gastric Motor Function Assessed by Magnetic Resonance Imaging in Healthy Volunteers: A Randomized, Double-Blind, Placebo-Controlled Trial. PLoS One. 2015 Sep 24;10(9):e0138927. doi: 10.1371/journal.pone.0138927. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Functional dyspepsia (FD) is a disorder characterized by chronic or recurrent upper abdominal pain or discomfort in the absence of a specific structural cause. Improving gastric accommodation and prokinetic effect seem to be an attractive physiological target in patients with FD. Motilitone (Dong-A ST, Yongin, Korea) is a new herbal drug that was launched in December 2011 in Korea for treating patients with FD. The current study aims to evaluate effects of motilitone on gastric accommodation and emptying after a meal in a group of healthy volunteers using three-dimensional gastric volume measurements by magnetic resonance imaging (MRI). Healthy volunteers are randomly allocated to receive either motilitone or placebo in a double blinded manner. After 5 days of treatment, subjects undergo gastric MRI. The primary endpoint is gastric accommodation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between 20 and 70 years of age without upper abdominal pain or discomfort and a structural abnormality on upper gastrointestinal (GI) endoscopy performed within the preceding 6 months were eligible for the trial.\n\nExclusion Criteria:\n\n* Patients were excluded if they met any of the following criteria:\n\n 1. any functional GI disease or previous abdominal surgery\n 2. diabetes mellitus under insulin or oral anti-hyperglycemic agent treatment\n 3. significant cardiopulmonary diseases or any malignancies\n 4. significant renal (serum creatinine level ≥ 1.5 × the upper normal limit) or liver disease (serum aspartate aminotransferase and alanine aminotransferase levels ≥ 2.5 × the upper normal limits\n 5. taking medications that may alter gastric function within 2 weeks prior to the start of the study\n 6. pregnancy or lactation\n 7. females with inadequate contraception during the study period\n 8. contraindications to MRI (e.g., cardiac pacemaker or metallic aneurysm clip)\n 9. allergic history to motilitone\n 10. other conditions likely to interfere with study procedures, as judged by the investigator'}, 'identificationModule': {'nctId': 'NCT02091635', 'briefTitle': 'Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Efficacy of Motilitone on Gastric Accommodation in Healthy Adult Patients: Evaluation Using MRI Method', 'orgStudyIdInfo': {'id': 'Motilitone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Motilitone', 'description': 'Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).', 'interventionNames': ['Drug: Placebo (for Motilitone)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (for Motilitone)', 'description': 'Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).', 'interventionNames': ['Drug: Motilitone']}], 'interventions': [{'name': 'Placebo (for Motilitone)', 'type': 'DRUG', 'otherNames': ['Sugar pill manufactured to mimic Motilitone 60mg tablet'], 'description': 'Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).', 'armGroupLabels': ['Motilitone']}, {'name': 'Motilitone', 'type': 'DRUG', 'otherNames': ['DA-9701'], 'description': 'Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).', 'armGroupLabels': ['Placebo (for Motilitone)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Poong-Lyul Rhee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}