Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-18 @ 5:32 PM
Study NCT ID:
NCT02244268
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2014-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3629}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-18', 'studyFirstSubmitDate': '2014-09-18', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in obstructive BPH symptoms', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change in irritative BPH symptoms', 'timeFrame': 'up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Residual Urine volume', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Assessment of the number of days on sick leave', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Global assessment of efficacy by investigator on a 4-point scale', 'timeFrame': 'after 12 weeks'}, {'measure': 'Change in Quality-of-Life Index', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Global assessment of tolerability by investigator on a 4-point scale', 'timeFrame': 'after 12 weeks'}, {'measure': 'Changes in urinary flow rate', 'timeFrame': 'up to 12 weeks'}]}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from symptomatic benign prostatic hyperplasia (BPH) syndrome recruited in urological practices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information\n\nExclusion Criteria:\n\nNo exclusion criteria is defined, prescribing information is to be considered'}, 'identificationModule': {'nctId': 'NCT02244268', 'briefTitle': 'Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome', 'orgStudyIdInfo': {'id': '527.20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with symptomatic of benign prostatic hyperplasia', 'interventionNames': ['Drug: ALNA®']}], 'interventions': [{'name': 'ALNA®', 'type': 'DRUG', 'otherNames': ['tamsulosin'], 'armGroupLabels': ['Patient with symptomatic of benign prostatic hyperplasia']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}