Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-04-22 @ 8:31 AM
Study NCT ID:
NCT02372903
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2015-02-13', 'studyFirstSubmitQcDate': '2015-02-21', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Pelvic pain as measured by visual analogue scale', 'timeFrame': 'Change from Baseline Pelvic Pain at 90 days of treatment'}], 'secondaryOutcomes': [{'measure': 'Change of Pelvic pain as measured by visual analogue scale', 'timeFrame': 'Change from baseline Pelvic Pain after 30 days from the suspension of the therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Chronic Pelvic Pain']}, 'descriptionModule': {'briefSummary': 'One of the main symptoms of endometriosis is pain, but his pathogenesis is not fully understood. The detection of mast cells in the endometriosis lesions supports the hypothesis that mast cell degranulation may contribute to development of pain and hyperalgesia.\n\nN-acylethanolamines (NAEs) are a class of endogenous compounds that regulate inflammation and pain, controlling mast-cell activation. The aim of the study is to investigate the efficacy of palmitoylethanolamide-polydatin combination on pain relief in symptomatic patients with endometriosis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 50 years;\n* pain visual analog scale (VAS) score\\>4\n* laparoscopic diagnosis of endometriosis (performed in the last three years),\n* no assumption of any drugs (in particularly estro-progestinic, progestinic, gonadotropin-releasing hormone (GnRH) agonists and antagonists)\n* persistence of symptoms by at least one month\n\nExclusion Criteria:\n\n* presence of other associated diseases\n* assumption of drugs\n* menopause\n* pregnancy\n* unable or unwilling to give written consent patients\n* adverse reaction or hypersensitivity to active substance or excipients'}, 'identificationModule': {'nctId': 'NCT02372903', 'briefTitle': 'Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Cagliari'}, 'officialTitle': 'Pilot Study About Efficacy of Palmitoylethanolamide-polydatin Combination on Chronic Pelvic Pain in Patients With Laparoscopic Diagnosis of Endometriosis', 'orgStudyIdInfo': {'id': 'PELV_25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endometriosis', 'description': 'Symptomatic patients with laparoscopic diagnosis of endometriosis', 'interventionNames': ['Drug: Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin']}], 'interventions': [{'name': 'Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin', 'type': 'DRUG', 'description': 'Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days', 'armGroupLabels': ['Endometriosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09042', 'city': 'Monserrato', 'state': 'Cagliari', 'country': 'Italy', 'facility': 'University of Cagliari,Obstetrics and Gynecological Department,', 'geoPoint': {'lat': 39.25642, 'lon': 9.1444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cagliari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefano Angioni', 'investigatorAffiliation': 'University of Cagliari'}}}}