Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01852318
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
1. 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.
2. Patients whose pruritus occurred only during dialysis
3. 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.
4. 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).
5. 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.
6. Patients with uncontrolled psychiatric disease, active malignancy, and untreated hypothyroidism.
7. Female patients who are pregnant, are nursing, or want to become pregnant.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01852318
Study Brief:
Protocol Section:
NCT01852318