Please select the eligibility criteria that correspond to the clinical trial below.
Title: Efficacy of Pregabalin in the Management of Chronic Uremic Pruritus
Brief 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.


Options:
A: Inclusion Criteria:

* Subject has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
* Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
* Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
* Have demonstrated pruritus intensity on the Itch NRS during screening
* Male or female who are at least 18 years old at the time of Screening

Exclusion Criteria:

* Subject had a significant alteration in dialysis regimen during the Screening Period
* Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
* Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
* Has had a history of substance abuse within 6 months prior to completing Screening
* Subject has a known drug allergy to opioids
* Subject is a pregnant or lactating female.
B: Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs
* visual analogue scale (VAS) equal or more than 4

Exclusion Criteria:

* Liver disease
* Respiratory disease
* Dermatological disease
* Hemoglobin less than 10
* Cholestasis
* Malignancies
C: 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.
D: Inclusion Criteria:

* Adult Chinese male and female patients aged \> 18 undergoing CAPD for at least 3 months and able to read and understand Chinese
* Patients experiencing moderate to severe pruritis, defined as persistent, treatment-resistant pruritis considerably impairing sleep or daytime activity. Treatment resistance is defined as no or only partial resolvement of pruritis under current anti-pruritis treatment regimens such as anti-pruritis lotions and anti-histamines.
* Patients in stable clinical condition in terms of peritoneal dialysis and general health
* Patients able to understand and answer the SDS questionnaire
* Patients able to express the sensation of itchiness in the terms of the VAS and the SDS score
* Patients who are willing to give written informed consent and to participate in and comply with the study protocol

Exclusion Criteria:

* Patients with a known history of pruritis or dermatologic disease antedating renal failure.
* Patients with skin disease other than the usual cutaneous findings of uraemia such as xerosis or ecchymosis.
* Patients under current treatment with systemic steroids
* Known history of allergy to Gabapentin
* Those patients already put on anti-convulsants
* Unable to give written informed consent for the study
* Pregnancy or female patients of child-bearing age who are unwilling to use contraception
* Poor drug compliance
* Known HIV positivity
* Active neoplastic disease
* Those who do not want to participate the study

Answer: C