Status:
UNKNOWN
Pregabalin for the Treatment of Uremic Pruritus
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Cathay General Hospital
Conditions:
Uremic Pruritus
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 r...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01852318
Start Date
April 1 2014
End Date
May 1 2015
Last Update
April 15 2014
Active Locations (1)
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1
National Taiwan University (NTUH); NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch; Cathay General hospital
Taipei, Taiwan, Taiwan, 100; 300; 640; 280