Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-24 @ 11:50 PM
Study NCT ID:
NCT02181959
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2014-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-17', 'studyFirstSubmitDate': '2014-07-02', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2014-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 60 days'}, {'measure': 'Assessment of overall tolerability rate on a 4-point scale', 'timeFrame': 'Day 30 and 60'}], 'secondaryOutcomes': [{'measure': 'Number of patients with abnormal changes in laboratory parameters', 'timeFrame': 'Day 0, 30 and 60'}, {'measure': 'Number of patients with abnormal findings in physical examination', 'timeFrame': 'Day 0, 30 and 60'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy man or woman, between 20 to 70 years\n* Fit to work\n* Volunteers have given informed consent and signed the consent form\n\nExclusion Criteria:\n\n* Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc)\n* Treatment with other drugs that might interfere with the evaluation of the safety of the test drug\n* Known hypersensitivity to any ingredients of the study drug\n* Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive\n* Drug and alcohol abuse\n* Participation in another trial\n* Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)'}, 'identificationModule': {'nctId': 'NCT02181959', 'briefTitle': 'Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Safety and Tolerability of PHARMATON Capsules vs PHARMATON Capsules With DMAE vs Placebo in Healthy Volunteers (A Double-blind, Controlled Multicentre Study)', 'orgStudyIdInfo': {'id': '1114.10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pharmaton® with DMAE', 'interventionNames': ['Drug: Pharmaton® with DMAE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pharmaton® without DMAE', 'interventionNames': ['Drug: Pharmaton® without DMAE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Pharmaton® with DMAE', 'type': 'DRUG', 'armGroupLabels': ['Pharmaton® with DMAE']}, {'name': 'Pharmaton® without DMAE', 'type': 'DRUG', 'armGroupLabels': ['Pharmaton® without DMAE']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}