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Pregabalin for the Treatment of Uremic Pruritus

Primary Purpose

Uremic Pruritus

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
pregabalin 75mg daily for 12 weeks
fexofenadine 60 mg daily for 12 weeks
placebo
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uremic Pruritus focused on measuring uremic pruritus, pregabalin, gabapentin, fexofenadine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who have end-stage renal disease (ESRD) on maintenance hemodialysis more than twice weekly for at least three months and suffered from uremic pruritus.
  • 20 Years and older
  • Definition of uremic pruritus:

Patients were considered to have pruritus if they had either of the following conditions:

  • at least 3 episodes of itch during a period of 2 weeks or less, with the symptom appearing a few times a day, lasting at least a few minutes, and troubling the patient
  • he appearance of an itch in a regular pattern during a period of 6 months, but less frequently than listed above.

To be defined as "uremic," the pruritus had to appear shortly before the onset of dialysis, or at any time after that, without evidence of any other active disease that could explain the pruritus.

-Patients who suffer from severe pruritus unresponsive to topical emollient and corticosteroids, and were diagnosed as having uremic pruritus by dermatologists

Exclusion Criteria:

  1. All patients with pruritus attributable to any other causes, such as scabies or other evident skin diseases (atopic dermatitis, psoriasis, generalized dermatitis, pediculosis, urticaria …etc), and any medication with potential pruritic properties.
  2. Patients whose pruritus occurred only during dialysis
  3. Patients received oral drugs with presumed antipruritic effect, including benzodiazepines, muscle relaxants, opioid analgesics, tricyclic antidepressants and antiepileptic drugs, or ultraviolet B phototherapy in the past one week prior to participate in this trial or during the trial.
  4. Concomitant elevation of liver enzymes (GOT: male >37 U/L, female:>31 U/L, GPT: male >41 U/L, female:>31U/L), alkaline phosphatase (ALP>104U/L), bilirubin (T-bil>1.2 mg/dL), serum phosphorus (>7 mg/dl), serum parathyroid hormone (>300 pg/ml).
  5. Patients who have the history of allergy to pregabalin, any acute illness, liver cirrhosis, hepatic failure, decompensated heart failure, inability to give informed consent, or poor compliance.
  6. Patients with uncontrolled psychiatric disease, active malignancy, and untreated hypothyroidism.
  7. Female patients who are pregnant, are nursing, or want to become pregnant.

Sites / Locations

  • National Taiwan University (NTUH); NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch; Cathay General hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Pregabalin

fexofenadine

Placebo

Arm Description

pregabalin 75mg daily for 12 weeks

fexofenadine 60 mg daily for 12 weeks

placebo 75 mg for 12 weeks

Outcomes

Primary Outcome Measures

The changes in pruritus symptoms assessed by VAS
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.

Secondary Outcome Measures

The changes in pruritus score (PS), Skindex-10", "Brief Itching Inventory" and Itch Medical Outcomes Study
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.

Full Information

First Posted
May 8, 2013
Last Updated
April 13, 2014
Sponsor
National Taiwan University Hospital
Collaborators
Cathay General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01852318
Brief Title
Pregabalin for the Treatment of Uremic Pruritus
Official Title
A Multicenter, Double-blind, Randomized, Placebo and Active-controlled Study of Pregabalin for the Treatment of Uremic Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Cathay General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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. Objectives: To investigate the efficacy and the safety of pregabalin, as compared with fexofenadine and placebo, in the treatment of uremic pruritus. Methods: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Pruritus
Keywords
uremic pruritus, pregabalin, gabapentin, fexofenadine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm Description
pregabalin 75mg daily for 12 weeks
Arm Title
fexofenadine
Arm Type
Active Comparator
Arm Description
fexofenadine 60 mg daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 75 mg for 12 weeks
Intervention Type
Drug
Intervention Name(s)
pregabalin 75mg daily for 12 weeks
Intervention Description
oral pregabalin 75mg daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
fexofenadine 60 mg daily for 12 weeks
Intervention Description
fexofenadine 60 mg daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
The changes in pruritus symptoms assessed by VAS
Description
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.
Time Frame
Week0, week1-12, Week 14
Secondary Outcome Measure Information:
Title
The changes in pruritus score (PS), Skindex-10", "Brief Itching Inventory" and Itch Medical Outcomes Study
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have end-stage renal disease (ESRD) on maintenance hemodialysis more than twice weekly for at least three months and suffered from uremic pruritus. 20 Years and older Definition of uremic pruritus: Patients were considered to have pruritus if they had either of the following conditions: at least 3 episodes of itch during a period of 2 weeks or less, with the symptom appearing a few times a day, lasting at least a few minutes, and troubling the patient he appearance of an itch in a regular pattern during a period of 6 months, but less frequently than listed above. To be defined as "uremic," the pruritus had to appear shortly before the onset of dialysis, or at any time after that, without evidence of any other active disease that could explain the pruritus. -Patients who suffer from severe pruritus unresponsive to topical emollient and corticosteroids, and were diagnosed as having uremic pruritus by dermatologists Exclusion Criteria: All patients with pruritus attributable to any other causes, such as scabies or other evident skin diseases (atopic dermatitis, psoriasis, generalized dermatitis, pediculosis, urticaria …etc), and any medication with potential pruritic properties. Patients whose pruritus occurred only during dialysis Patients received oral drugs with presumed antipruritic effect, including benzodiazepines, muscle relaxants, opioid analgesics, tricyclic antidepressants and antiepileptic drugs, or ultraviolet B phototherapy in the past one week prior to participate in this trial or during the trial. Concomitant elevation of liver enzymes (GOT: male >37 U/L, female:>31 U/L, GPT: male >41 U/L, female:>31U/L), alkaline phosphatase (ALP>104U/L), bilirubin (T-bil>1.2 mg/dL), serum phosphorus (>7 mg/dl), serum parathyroid hormone (>300 pg/ml). Patients who have the history of allergy to pregabalin, any acute illness, liver cirrhosis, hepatic failure, decompensated heart failure, inability to give informed consent, or poor compliance. Patients with uncontrolled psychiatric disease, active malignancy, and untreated hypothyroidism. Female patients who are pregnant, are nursing, or want to become pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-Yi Chiu, MD
Phone
0972654317
Email
extra.owl0430@yahoo.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Tsen-Fang Tsai, MD
Phone
886-2-23123456
Ext
2141
Email
tftsai@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsien-Yi Chiu, MD
Organizational Affiliation
2. Department of Dermatology, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University (NTUH); NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch; Cathay General hospital
City
Taipei
ZIP/Postal Code
100; 300; 640; 280
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-Yi Chiu, MD
Phone
0972654317
Email
extra.owl0430@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Hsien-Yi Chiu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33283264
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.
Results Reference
derived

Learn more about this trial

Pregabalin for the Treatment of Uremic Pruritus

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