ACTRN12621001626853招募中2 期
A Phase II, prospective, open-label, dual-centre, single-arm feasibility study of Pregabalin for the management of uraemic pruritus in patients with End Stage Kidney Disease (ESKD) who are conservatively managed.
niversity of Technology Sydney0 个研究点目标入组 24 人开始时间: 2021年11月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •18 years of age or more.
- •CKD 5 (eGFR<15) or CKD 4 (eGFR 15 -30)
- •Moderate to severe uraemic pruritus (WI-NRS=3) and chronic itch (> 6 weeks)
- •Able to read study questionnaires (5th grade level) in English.
- •Able to provide fully informed written consent
- •Capable of completing assessments, study diary and complying with the study procedures
排除标准
- •Itch not related to uraemic pruritus (as determined by a clinician). i.e. itch related to dermatological conditions, liver failure or cholestatic pruritus, neurological (post-herpetic neuralgia) and psychogenic disease.
- •Suicidality item in MADRS score >4
- •Known allergy or previous intolerance to Gabapentinoids (Pregabalin and Gabapentin).
- •Use of Gabapentinoids within the last 2 weeks.
- •High phosphate (PO4>2.5), corrected calcium (Ca2+>2.7) and low haemoglobin (Hb <80), Serum Iron (Fe2+>4)
- •Clinician predicted survival less than one month
- •Pregnant or breastfeeding
- •Chronic alcoholism or drug abuse
- •Australian-modified Karnofsky performance score (AKPS) less than 50 at the beginning of the study
- •Participated in a clinical study of a new chemical entity within the month prior to study randomization
研究者
相似试验
进行中（未招募）
1 期
A phase II, multicentre, open label, prospective, interventional study to evaluate the sperm DNA fragmentation in idiopathic male infertility before and after treatment with Gonal-f PEN 900 IU. - NDIdiophatic male infertilityMedDRA version: 9.1Level: SOCClassification code 10014698EUCTR2010-020196-23-ITMERCK SERONO SPA
进行中（未招募）
不适用
A phase II, open-label, prospective, multicenter study to evaluate theefficacy and safety of subsequent treatment with the Zevalin(ibritumomab tiuxetan) study in patients with follicular grade I-IIlymphoma after 4 cycles of Fludarabine-Mitoxantrone-Rituximab(FMR) therapy. - NDEUCTR2006-004850-26-ITAZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
已完成
2 期
A clinical study to compare safety and efficacy of two brands of buprenorphine (XPRENOR and SUBUTEX) in patients who are opioid dependent.CTRI/2013/06/003782Martindale Pharma54
进行中（未招募）
1 期
Efficacy and safety of treatment with alpelisib plus endocrine therapy in patients with HR+, HER2- negative aBC, with PIK3CA mutations, whose disease has progressed on or after CDK 4/6 treatment with an aromatase inhibitor (AI) or fulvestrantHormone receptor positive, HER2-negative advanced breast cancerMedDRA version: 19.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2016-004586-67-ESovartis Farmacéutica, S.A.160
终止
不适用
Efficacy and Safety of 80 mg Osimertinib in Patients With Leptomeningeal Metastases (LM) Associated With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Non-small Cell Lung CancerKCT0005540Samsung Medical Center80