Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

NCT03758079 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 064-17/717
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single blind randomized trial to compare efficacy and side effects of Gabapentin with Doxepin. Hemodialysis patients with uremic pruritus at one dialysis center of Saint George Hospital University Medical Centre were included in this study. Patients were divided into 2 groups to receive either 10 mg Doxepin daily or Gabapentin at a dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks, after which patients were treated reversley. Pruritus severity and its effect on quality of life will be assessed by using visual analog scale (VAS), 5-D pruritus scale and dermatology life quality index (DLQI). Include patients will have to fill these forms at baseline and at end of week1, week2 and week4

Conditions

Uremic Pruritus

Outcome Measures

Primary Outcomes (3)

• Change from baseline in Worst-itching Visual Analog Scale (VAS) at week 4

  a 10cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored as follows: no pruritus (VAS score 0), mild (VAS score 1-3) with episodic and localized pruritus without disturbance in usual work and sleep, moderate (VAS score 4-7) with generalized and continuous pruritus without sleep disturbance and severe (VAS score 8-10) with generalized, continuous pruritus and sleep disturbance.

  1, 2, 4 weeks

• Change from baseline in 5-D Itch Scale score at week 4

  multidimensional questionnaire. The five dimensions are degree, duration, direction, disability and distribution. The scores of each of the five domains will be achieved separately and then summed together to obtain a total 5-D score ranging between five (no pruritus) and 25 (most severe pruritus). For the distribution domain, the number of affected body parts is tallied (potential sum 0-16) and the sum is sorted into five scoring bins: sum of 0-21⁄4score of 1, sum of 3-51⁄4score of 2, sum of 6-101⁄4score of 3, sum of 11-131⁄4score of 4 and sum of 14-161⁄4score of 5

  1, 2, 4 weeks

• Change from baseline in Dermatology life quality index (DLQI) at week 4

  10-Item questionnaire evaluating: impact of skin condition on HRQoL during the past week, symptoms and feeling, daily activities, leisure, work and school, personal relationships, treatment. A Score range from 0 to 30.

  1, 2, 4 weeks

Secondary Outcomes (1)

• side effects of each treatment

  4 weeks

Study Arms (2)

Doxepin

ACTIVE COMPARATOR

10 mg Doxepin daily for 4 weeks

Drug: Doxepin

Gabapentin

ACTIVE COMPARATOR

Gabapentin 100mg after each dialysis session

Drug: Gabapentin

Interventions

Doxepin DRUG

10 mg Doxepin for 4 weeks

Also known as: Silenor, Sinequan, Adapin

Doxepin

Gabapentin DRUG

dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks

Also known as: Neurontin, Gralise, Gabarone, Fanatrex

Gabapentin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prevalent patients undergoing HD with UP for at least three months
• any medications with antipruritic effects to be discontinued one week before the study
• Hemodialysis performed for 3-4 h thrice weekly via a low flux polysulphonedialyser \[1.3-1.6 m2 surface areas\] using bicarbonate and/or acetate dialysis fluid
• well controlled Calcium, Phosphorus and iPTH levels

You may not qualify if:

• patients labeled high risk of fall (Having a score more than 16/20 using part 1 from Falls Risk Assessment Tool (FRAT)
• patients taking drugs that interact with doxepin or gabapentin
• patients with hepatic failure
• patients with hyperthyroidism
• patients with narrow angle glaucoma
• patients with heart block or decompensated heart failure or hypotension (defined as systolic blood pressure less than 90 mmHg) or myocardial infarction in the past three months
• history of allergy to gabapentin or doxepin
• uncontrolled psychiatric diseases
• pregnant patients
• patients with psoriasis, atopic dermatitis or any other condition that can justify the pruritus

Sponsors & Collaborators

• University of Balamand: lead

Study Sites (1)

Saint George Hospital University Medical Center

Beirut, Lebanon

Location

MeSH Terms

Interventions

Doxepin; Gabapentin

Intervention Hierarchy (Ancestors)

Oxepins; Ethers, Cyclic; Ethers; Organic Chemicals; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Roger N Haber, MD

  University of Balamand/Saint George Hospital University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 29, 2018
• Study Start: June 1, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11

Locations

LE (1)