Pregabalin for the Treatment of Uremic Pruritus

NCT01852318 | Unknown Phase 4

• 2 other identifiers: 201301065MINBT-NTUH-8407
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Uremic Pruritus

Keywords

uremic pruritus; pregabalin; gabapentin; fexofenadine

Outcome Measures

Primary Outcomes (1)

• 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.

  Week0, week1-12, Week 14

Secondary Outcomes (1)

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

  PS: Week0, week1-12, Week 14; Skindex-10", "Brief Itching Inventory" and Itch Medical Outcomes Study (MOS): week0, 3,6, 9, 12, 14

Study Arms (3)

Pregabalin

EXPERIMENTAL

pregabalin 75mg daily for 12 weeks

Drug: pregabalin 75mg daily for 12 weeks

fexofenadine

ACTIVE COMPARATOR

fexofenadine 60 mg daily for 12 weeks

Drug: fexofenadine 60 mg daily for 12 weeks

Placebo

PLACEBO COMPARATOR

placebo 75 mg for 12 weeks

Drug: placebo

Interventions

pregabalin 75mg daily for 12 weeks DRUG

oral pregabalin 75mg daily for 12 weeks

Pregabalin

fexofenadine 60 mg daily for 12 weeks DRUG

fexofenadine 60 mg daily for 12 weeks

fexofenadine

placebo DRUG

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Cathay General Hospital: collaborator

Study Sites (1)

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

Taipei, Taiwan, 100; 300; 640; 280, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 33283264 DERIVED

MeSH Terms

Interventions

Pregabalin; fexofenadine

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hsien-Yi Chiu, MD

  2. Department of Dermatology, National Taiwan University Hospital, Hsin-Chu Branch, Hsin-Chu, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsien-Yi Chiu, MD

CONTACT

0972654317; extra.owl0430@yahoo.com.tw

Tsen-Fang Tsai, MD

CONTACT

886-2-23123456; tftsai@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

TW (1)