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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Uremic Pruritus
 Drug: Pregabalin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Resource links provided by NLM:

MedlinePlus related topics: Itching
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Reduction of UP by more than 50% after Pregabalin administration [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration [ Time Frame: 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo versus pregabalin
 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
Experimental: Pregabalin
Placebo versus pregabalin
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01073501

Contacts
Contact: LINDA SHAVIT, MD 97226555086 lshavit@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel, 91031
Contact: LINDA SHAVIT, MD     97226555086     lshavit@szmc.org.il    
Principal Investigator: linda shavit, MD            
Sponsors and Collaborators
Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Shavit Linda MD, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT01073501     History of Changes
Other Study ID Numbers: 111.CT.IL
Study First Received: February 17, 2010
Last Updated: February 22, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Shaare Zedek Medical Center:
UREMIC PRURITUS
PREGABALIN
UP

Additional relevant MeSH terms:
Pruritus
Skin Diseases
Skin Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 23, 2013