Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01073501
First received: February 17, 2010
Last updated: February 22, 2010
Last verified: February 2010

February 17, 2010
February 22, 2010
April 2010
March 2012   (final data collection date for primary outcome measure)
Reduction of UP by more than 50% after Pregabalin administration [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01073501 on ClinicalTrials.gov Archive Site
Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration [ Time Frame: 2012 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced or end-stage renal disease. Its intensity ranges from sporadic discomfort to complete restlessness during both the day- and night-time and its distribution varies significantly over time. Many attempts have been made to relieve this bothersome symptom in affected patients, however with generally limited success. Incidence of UP varies widely between studies and seems to decline over the last 30 years (from 85% in the 1970s and 50-60% in the 1980s to a 22% in the 2000s) (Gunal AI).

We use Pregabalin for the relief of diabetic neuropathic pain in patients on haemodialysis in our centre. In addition to neuropathic pain, several of our patients have complained of pruritus and after Pregabalin treatment, their pruritus has promptly and completely resolved. Accordingly, we intend to conduct a double-blind, placebo-controlled, crossover trial to assess the effectiveness of Pregabalin in chronic UP.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Uremic Pruritus
  • Drug: Pregabalin
    Pregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
  • Drug: Placebo
    Pregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
  • Placebo Comparator: Placebo
    Placebo versus pregabalin
    Intervention: Drug: Placebo
  • Experimental: Pregabalin
    Placebo versus pregabalin
    Intervention: Drug: Pregabalin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
36
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. History of pruritus of >8 weeks duration.
  2. Severity of pruritus of 7 or more defined by visual analogue scale.
  3. No improvement by oral antihistamines or skin moisturizers.
  4. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study.
  5. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

  1. Known allergy to Pregabalin
  2. Any acute illness;
  3. Liver cirrhosis
  4. Active dermatological disorder other than UP
  5. Decompensated heart failure;
  6. Inability to give informed consent;
  7. Poor compliance.
Both
18 Years and older
No
Contact: LINDA SHAVIT, MD 97226555086 lshavit@szmc.org.il
Israel
 
NCT01073501
111.CT.IL
Not Provided
Shavit Linda MD, Shaare Zedek Medical Center
Shaare Zedek Medical Center
Not Provided
Not Provided
Shaare Zedek Medical Center
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP