Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT07270432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy/ Safety of Product DNN.65.21.005 in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 218}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-26', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2025-11-26', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in International Prostate Symptom Score (IPSS)', 'timeFrame': '180 days', 'description': 'Change in International Prostate Symptom Score (IPSS) evaluated 180 days after starting treatment compared to the baseline'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostatic Hyperplasia, Benign']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male participants aged 50 years and older.\n* Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).\n* Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.\n\nExclusion Criteria:\n\n* History or evidence of prostate cancer.\n* Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.\n* Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.\n* Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.\n* Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.\n* Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment.\n* Use of any prohibited medications within the timeframe specified in the study protocol.\n* Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study."}, 'identificationModule': {'nctId': 'NCT07270432', 'acronym': 'NICCOLO', 'briefTitle': 'Efficacy/ Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ache Laboratorios Farmaceuticos S.A.'}, 'officialTitle': 'Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'ACH-DTS-03(03/22)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Product DNN.65.21.005', 'interventionNames': ['Drug: Product DNN.65.21.005']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combodart®', 'interventionNames': ['Drug: Combodart®']}], 'interventions': [{'name': 'Product DNN.65.21.005', 'type': 'DRUG', 'description': 'One capsule every 24 hours', 'armGroupLabels': ['Product DNN.65.21.005']}, {'name': 'Combodart®', 'type': 'DRUG', 'description': 'One capsule every 24 hours', 'armGroupLabels': ['Combodart®']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ache Laboratorios Farmaceuticos S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}