Pregabalin for the Treatment of Uremic Pruritus
|ClinicalTrials.gov Identifier: NCT01852318|
Recruitment Status : Unknown
Verified April 2014 by National Taiwan University Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 13, 2013
Last Update Posted : April 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Uremic Pruritus||Drug: pregabalin 75mg daily for 12 weeks Drug: fexofenadine 60 mg daily for 12 weeks Drug: placebo||Phase 4|
Pruritus s a very distressing problem affecting patients with uremia and the prevalence of uremic pruritus (UP) ranges between 22% to 66%. Although some studies suggested pruritus is being decreased recently by use of better dialysis techniques, accumulating studies have shown the still high prevalence of UP. Because of its long duration, frequency and high intensity, UP has been reported to have a negative impact upon the patients' quality of life (QoL). However, the therapies in use, including antihistamines, ultraviolets, opioid antagonists and topical agents, are generally of insufficient efficacy, failing to provide adequate and long-lasting relief. Based on the neuropathic hypothesis and frequent co-occurrence of chronic pruritus and peripheral neuropathy in the patients undergoing hemodialysis, gabapentin, a medication widely used for a spectrum of neuropathic pain syndromes, has recently been suggested to be effective in the treatment of UP.
Pregabalin, another gabaergic drug structurally related to gabapentin, have an advantage over gabapentin in terms of its more rapid response to stressful symptoms. Only two very recently small-scaled studies evaluate the effect of pregabalin for UP. However, both these studies were not randomized, placebo-controlled trails.
Studies focusing on the treatment of UP were limited and no studies comparing the efficacy between pregabalin and antihistamine, most widely used for the therapy of UP currently, were conducted. Additionally. there were few studies investigating the effect of the drugs used for UP on the QoL outcomes, though UP has a great impact on the patients' QoL. As UP is still one of the most vexing and disabling symptoms in patients with ESRD, we decided to do this multicenter, randomized double-blind placebo-controlled trial (RCT) with a larger sample size and a longer duration.
To investigate the efficacy and the safety of pregabalin, as compared with fexofenadine and placebo, in the treatment of uremic pruritus.
This is a multicenter RCT. Haemodialysis patients with established UP were enrolled from multiple medical centers in Taiwan. All patients will be randomly allocated to receive one of three treatments —pregabalin 75mg daily, fexofenadine 60 mg daily, or placebo—for 12 weeks. The primary endpoint of the study is the change in the visual analogue score and pruritus score. The changes in QoL measures, including Skindex-10, Brief Itching Inventory and Itch Medical Outcomes Study, are also assessed before, during and after therapy. Safety is assessed at all visits throughout the study. A follow-up visit will be performed 2 weeks after administration of the final dose of study
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Double-blind, Randomized, Placebo and Active-controlled Study of Pregabalin for the Treatment of Uremic Pruritus|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||May 2015|
pregabalin 75mg daily for 12 weeks
Drug: pregabalin 75mg daily for 12 weeks
oral pregabalin 75mg daily for 12 weeks
Active Comparator: fexofenadine
fexofenadine 60 mg daily for 12 weeks
Drug: fexofenadine 60 mg daily for 12 weeks
fexofenadine 60 mg daily for 12 weeks
Placebo Comparator: Placebo
placebo 75 mg for 12 weeks
- The changes in pruritus symptoms assessed by VAS [ Time Frame: Week0, week1-12, Week 14 ]All participants will receive telephone interviewed by CRC every week and the severity, intensity, frequency and distribution of pruritus are evaluated by visual analogue scale (VAS)at the baseline of the study, every week throughout the treatment period and 2 weeks after administration of the final dose of study medication.
- The changes in pruritus score (PS), Skindex-10", "Brief Itching Inventory" and Itch Medical Outcomes Study [ Time Frame: PS: Week0, week1-12, Week 14; Skindex-10", "Brief Itching Inventory" and Itch Medical Outcomes Study (MOS): week0, 3,6, 9, 12, 14 ]All participants will receive telephone interviewed by CRC every week and the severity, intensity, frequency and distribution of pruritus are evaluated by visual analogue scale (VAS) and pruritus score (PS)29-30 at the baseline of the study, every week throughout the treatment period and 2 weeks after administration of the final dose of study medication. Because uremic pruritus has a great potential to impair the patients's quality of life (QoL), we adapt"Skindex-10", "Brief Itching Inventory" and Itch Medical Outcomes Study (MOS), proposed previously by Mathur et al.,12 to assess the effect of pregabalin treatment on the health-related quality of life in hemodialysis patients. These QoL measures are evaluated by clinicians at the baseline, every three weeks during treatment period and 2 weeks after administration of the final dose of study medication.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852318
|Contact: Hsien-Yi Chiu, MDemail@example.com|
|Contact: Tsen-Fang Tsai, MD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University (NTUH); NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch; Cathay General hospital|
|Taipei, Taiwan, 100; 300; 640; 280|
|Contact: Hsien-Yi Chiu, MD 0972654317 email@example.com|
|Principal Investigator: Hsien-Yi Chiu, MD|
|Principal Investigator:||Hsien-Yi Chiu, MD||2. Department of Dermatology, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan|