Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT00577967
Status:
UNKNOWN
Last Update Posted:
2010-07-07
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gabapentin - A Solution to Uremic Pruritus?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D014511', 'term': 'Uremia'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077206', 'term': 'Gabapentin'}], 'ancestors': [{'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2006-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2007-12-19', 'studyFirstSubmitQcDate': '2007-12-19', 'lastUpdatePostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective measurement of reduction in pruritus', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Tolerability of Gabapentin in CAPD patients', 'timeFrame': '3 months'}]}, 'conditionsModule': {'keywords': ['Uremic pruritis'], 'conditions': ['Pruritus', 'Uremia']}, 'referencesModule': {'references': [{'pmid': '33283264', 'type': 'DERIVED', 'citation': 'Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.'}]}, 'descriptionModule': {'briefSummary': 'To investigate using the drug gabapentin to relieve the intense pruritic sensation associated with chronic renal failure patients undergoing peritoneal dialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult Chinese male and female patients aged \\> 18 undergoing CAPD for at least 3 months and able to read and understand Chinese\n* Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.\n* Patients in stable clinical condition in terms of peritoneal dialysis and general health\n* Patients able to understand and answer the SDS questionnaire\n* Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score\n* Patients who are willing to give written informed consent and to participate in and comply with the study protocol\n\nExclusion Criteria:\n\n* Patients with a known history of pruritis or dermatologic disease antedating renal failure.\n* Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.\n* Patients under current treatment with systemic steroids\n* Known history of allergy to Gabapentin\n* Those patients already put on anti-convulsants\n* Unable to give written informed consent for the study\n* Pregnancy or female patients of child-bearing age who are unwilling to use contraception\n* Poor drug compliance\n* Known HIV positivity\n* Active neoplastic disease\n* Those who do not want to participate the study'}, 'identificationModule': {'nctId': 'NCT00577967', 'briefTitle': 'Gabapentin - A Solution to Uremic Pruritus?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hospital Authority, Hong Kong'}, 'officialTitle': 'Gabapentin - A Solution to Uremic Pruritus? A Prospective, Randomized, Placebo-controlled, Double-blind Study', 'orgStudyIdInfo': {'id': '355/05'}, 'secondaryIdInfos': [{'id': 'HARECCTR0500020'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Gabapentin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'contacts': [{'name': 'Ka Hang Tong, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kay Tai Leung, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tze Hoi Kwan, Dr', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tak Cheung Au, Dr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Yui Pong Siu, Dr', 'role': 'CONTACT', 'email': 'maryvil@netivigator.com', 'phone': '(852) 2468 5750'}], 'overallOfficials': [{'name': 'Yui Pong Siu, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical and Geriatrics / Nephrology, Tuen Mun Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Authority, Hong Kong', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}]}}}