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Pregabalin for the Treatment of Uremic Pruritus

NCT01852318 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2014-04-15

No results posted yet for this study

Summary

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.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.

Conditions

  • Uremic Pruritus

Interventions

DRUG

pregabalin 75mg daily for 12 weeks

oral pregabalin 75mg daily for 12 weeks

DRUG

fexofenadine 60 mg daily for 12 weeks

fexofenadine 60 mg daily for 12 weeks

DRUG

placebo

Sponsors & Collaborators

  • Cathay General Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Hsien-Yi Chiu, MD · 2. Department of Dermatology, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01852318 on ClinicalTrials.gov