Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Uremic Pruritus Clinical Trial

Official title:

Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01073501
• Other study ID #: 111.CT.IL
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 17, 2010
• Last updated: February 22, 2010
• Start date: April 2010
• Est. completion date: March 2012

Study information

• Verified date: February 2010
• Source: Shaare Zedek Medical Center
• Contact: LINDA SHAVIT, MD
• Phone: 97226555086
• Email: lshavit[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pruritus
• Uremic Pruritus

Intervention

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
• 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

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of UP by more than 50% after Pregabalin administration		2012	No
Secondary	Reduction of chronic pain of various origin and improvement in insomnia after Pregabalin administration		2012	No