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Comparison of pregabalin with doxepin in the management of uremic pruritus

Comparison of pregabalin with doxepin in the management of uremic pruritus

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015060922637N1
Enrollment
70
Registered
2015-08-29
Start date
2015-05-31
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ESRD. End stage kidney disease on dialysis

Interventions

Intervention 1: Pregabalin (Oral Capsule 50 mg): The initial dose of pregabalin is 50 mg three times a week (after each dialysis session in hemodialysis patients). After one week, if response to the m
Treatment - Drugs
Pregabalin (Oral Capsule 50 mg): The initial dose of pregabalin is 50 mg three times a week (after each dialysis session in hemodialysis patients). After one week, if response to the medication is not
Doxepin (Oral Capsule 10 mg): The initial dose of doxepin is 10 mg per day. After 1 week, if response to the medication is not satisfactory, dose of the drug will be increased to 10 mg two times per d

Sponsors

Kerman University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: age between 16-80 years old; undergoing regular hemodialysis or peritoneal dialysis Exclusion criteria: history of allergy to pregabalin or doxepin; liver failure; pregnancy; history of epilepsy or a single episode of seizure; uncontrolled psychiatric illness; decompensated heart failure; narrow angle glaucoma; hyperthyroidism; history of myocardial infarction in the past three months; heart block; low blood pressure(Systolic blood pressure less than 90 mmHg)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Severity of pruritus. Timepoint: Before the intervention, and one week, two weeks and four weeks after the intervention. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
Severity of pruritus and its impact on the quality of life. Timepoint: Before the intervention, and one week, two weeks and four weeks after the intervention. Method of measurement: 5-D itch scale.;Effect of pruritus on the quality of life. Timepoint: Before the intervention and one week, two weeks and four weeks after the intervention. Method of measurement: Dermatology Life Quality Index (DLQI).;Adverse effects. Timepoint: At the end of the first and fourth weeks of the intervention. Method of measurement: Checklist of adverse effects.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNaemeh Nikvarz

Kerman University of Medical Sciences

nnikvarz@kmu.ac.ir+98 34 3121 5017

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026