Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02977832
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2016-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic 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': 'C047638', 'term': 'alfuzosin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'alpha-antagonist (alfuzosin 10 mg)+ Odyliresin (Iresine celosia) 2 ml, 20 drops once daily.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-26', 'studyFirstSubmitDate': '2016-11-28', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Prostate Symptom Score', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Maximum flow rate', 'timeFrame': '12 months'}, {'measure': 'Average flow rate', 'timeFrame': '12 months'}, {'measure': 'Adenoma volume', 'timeFrame': '12 months'}, {'measure': 'Residual urine volume', 'timeFrame': '12 months'}, {'measure': 'adverse events', 'timeFrame': '12 months'}, {'measure': 'Quality of life score', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['LUTS', 'Iresine celosia', 'Odyliresin', 'medical therapy'], 'conditions': ['Benign Prostatic Hypertrophy With Outflow Obstruction', 'Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '18533373', 'type': 'BACKGROUND', 'citation': 'Edwards JL. Diagnosis and management of benign prostatic hyperplasia. Am Fam Physician. 2008 May 15;77(10):1403-10.'}]}, 'descriptionModule': {'briefSummary': "Odyliresin (Iresine Celosia) is a cytochrome-flavoprotein with a powerful anti-oxydant action on cells, has a therapeutic effect on BPH-related LUTS, reducing symptoms, prostate volume, improving the patient's quality of life and eventually limiting the number of patients who require surgery or endoscopy after medical treatment.", 'detailedDescription': "The aim of this phase II open clinical trial was to determine if Odyliresin, given its unique chemical structure, has a therapeutic effect on BPH-related LUTS, so as to reduce symptoms, prostate volume, improve the patient's quality of life and eventually to limit number of patients who require surgery or endoscopy after medical treatment. To this aim, patients who seek specialist advice for LUTS with no previous surgical treatment for BPH have been selected for treatment with Odyliresin in addition to an alpha-antagonist, in order determine whether at 12 months a clinical result is obtained, if after 6 and 12 months BPH symptoms are significantly improved, and a reduction of prostatic volume can be observed, thus changing the usual course of the disease. All patients with BPH-related LUTS received both alphalitic and Odyliresin treatment, clinical parameters and uroflowmetry parameters significantly improved, adenoma volume and post-void residual volume were significantly reduced at 12 month. This is the first clinical experience with Iresine Celosia in BPH."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 45 years of age or older\n* Clinically diagnosed with mild to moderate BPH\n* Prostatic volume ≥ 30 ml determined by transrectal ultrasound\n* Maximum flow rate (Qmax) \\< 15 ml/sec for a voided volume 150-500 ml\n\nExclusion Criteria:\n\n* Participants must not have severe BPH (IPSS symptom score \\>21)\n* Participants should not be currently undergoing any other form of medical therapy for BPH (5-PDE inhibitors, mepartricine, plant extracts such as Saw Palmetto, vitamin E, and quercetin).\n* Patients must not have undergone prior transurethral resection of the prostate (TURP).\n* Post void residual (PVD) \\> 200 ml\n* Previous urological history including urethral stricture disease and/or bladder neck disease, urinary retention, bladder stone, chronic prostatitis, bladder cancer, interstitial cystitis, active upper tract stone disease causing symptoms, insulin-dependent diabetes mellitus and non-controlled non-insulin-dependent diabetes mellitus, chronic renal failure'}, 'identificationModule': {'nctId': 'NCT02977832', 'acronym': 'Odyliresin', 'briefTitle': 'Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'A Pilot Study of Clinical Results of Odyliresin (Iresine Celosia) in Symptomatic Benign Prostatic Hyperplasia', 'orgStudyIdInfo': {'id': 'IRCCSPSM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'odyliresin', 'description': 'Odyliresin (Iresine celosia) 2 ml', 'interventionNames': ['Dietary Supplement: Odyliresin', 'Drug: Alfuzosin']}, {'type': 'EXPERIMENTAL', 'label': 'alphalytic', 'description': 'alpha-antagonist (alfuzosin 10 mg)', 'interventionNames': ['Dietary Supplement: Odyliresin', 'Drug: Alfuzosin']}], 'interventions': [{'name': 'Odyliresin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Iresine Celosia'], 'description': 'Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)', 'armGroupLabels': ['alphalytic', 'odyliresin']}, {'name': 'Alfuzosin', 'type': 'DRUG', 'otherNames': ['alphalytic'], 'description': '10Mg Oral Tablet, Extended Release', 'armGroupLabels': ['alphalytic', 'odyliresin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Urology Department Fondazione IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'overallOfficials': [{'name': 'Carmine Tinelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ethics Committee'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Daniele Porru', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}