Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-04-13 @ 7:42 PM
Study NCT ID:
NCT02244320
Status:
COMPLETED
Last Update Posted:
2014-09-19
First Post:
2014-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)
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': 4150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, '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': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IPSS sum score', 'timeFrame': 'Day 1, 2 months'}, {'measure': 'Change in Quality-of-Life Index (QoL) rated on a 7-point scale', 'timeFrame': 'Day 1, 2 months'}], 'secondaryOutcomes': [{'measure': 'Change in sexual satisfaction rated on a 4-point scale', 'timeFrame': 'Day 1, 2 months'}, {'measure': 'Change in maximum urinary flow rate (ml/sec)', 'timeFrame': 'Day 1, 2 months'}, {'measure': 'Change in residual urine volume (ml)', 'timeFrame': 'Day 1, 2 months'}, {'measure': "Patient's global assessment of the preceding phytotherapy on a 3-point scale", 'timeFrame': 'Day 1'}, {'measure': "Patient's global assessment of the therapy with ALNA® on a 3-point scale", 'timeFrame': 'after 2 months'}, {'measure': 'Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale', 'timeFrame': 'Day 1'}, {'measure': 'Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale', 'timeFrame': 'after 2 months'}, {'measure': 'Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale', 'timeFrame': 'Day 1'}, {'measure': 'Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale', 'timeFrame': 'after 2 months'}, {'measure': 'Number of patients with adverse drug reactions (ADR)', 'timeFrame': 'up to 2 months'}]}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia']}, 'descriptionModule': {'briefSummary': 'The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with functional BPH symptoms recruited at urologist offices', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from BPH symptoms\n* Preceding treatment with a phytotherapeutic for at least 4 weeks\n* IPSS sum score ≥ 8 points prior to treatment start with ALNA®\n* Indication for a switch to treatment with ALNA® for a minimum period of 2 months\n\nExclusion Criteria:\n\n* Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency\n* Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study'}, 'identificationModule': {'nctId': 'NCT02244320', 'briefTitle': 'Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)', 'orgStudyIdInfo': {'id': '527.38'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'functional BPH', 'description': 'patients with functional BPH who switched from phytotherapy to ALNA®', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['ALNA®'], 'armGroupLabels': ['functional BPH']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}