## Protocol Section
### Identification Module
**NCT ID:** NCT03758079

**Brief Title:** Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus

**Official Title:** Comparison of Gabapentin With Doxepin in the Management of Uremic Pruritus: Pilot Study

#### Organization Study ID Info
**ID:** 064-17/717
#### Organization
**Class:** OTHER
**Full Name:** University of Balamand
### Status Module
#### Completion Date
**Date:** 2018-10-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-11-29

**Type:** ACTUAL

**Last Update Submit Date:** 2018-11-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-10-08

**Type:** ACTUAL

#### Start Date
**Date:** 2018-06-01

**Type:** ACTUAL

**Status Verified Date:** 2018-11

#### Study First Post Date
**Date:** 2018-11-29
**Type:** ACTUAL
**Study First Submit Date:** 2018-11-19
**Study First Submit QC Date:** 2018-11-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Balamand

#### Responsible Party

**Investigator Affiliation:** University of Balamand

**Investigator Full Name:** Julien Bachour, MD

**Investigator Title:** Principle Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** True

**Oversight Has DMC:** True

### Description Module

**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

**Detailed Description:** Pruritus is one of the frustrating skin manifestations of advanced renal failure. Many options have been used for the management of uremic pruritus (UP) such as Pregabalin, Gabapentin, Doxepine and Desloratidine. Gabapentin, a GABAergic drug, has been found to be effective in the treatment of uremic pruritus. Doxepin, a potent antihistamine drug, is used orally or topically in many pruritic conditions such as UP, idiopathic pruritus, atopic dermatitis, neurogenic, or psychogenic pruritus and, in the management of the UP in hemodialysis patients.

No comparative head to head study between Gabapentin and Doxepine has been conducted to date. The aim of this study was to compare Gabapentin and Doxepin in treatment of uremic pruritus in hemodialysis patients.

### Conditions Module

**Conditions:**

- Uremic Pruritus

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 10 mg Doxepin daily for 4 weeks

**Intervention Names:**

- Drug: Doxepin

**Label:** Doxepin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Gabapentin 100mg after each dialysis session

**Intervention Names:**

- Drug: Gabapentin

**Label:** Gabapentin

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Doxepin

**Description:** 10 mg Doxepin for 4 weeks

**Name:** Doxepin

**Other Names:**

- Silenor

- Sinequan

- Adapin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Gabapentin

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

**Name:** Gabapentin

**Other Names:**

- Neurontin

- Gralise

- Gabarone

- Fanatrex

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

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

**Time Frame:** 1, 2, 4 weeks

**Description:** 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

**Measure:** Change from baseline in 5-D Itch Scale score at week 4

**Time Frame:** 1, 2, 4 weeks

**Description:** 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.

**Measure:** Change from baseline in Dermatology life quality index (DLQI) at week 4

**Time Frame:** 1, 2, 4 weeks

#### Secondary Outcomes

**Description:** Number of patients who report side effects while on each treatment

**Measure:** side effects of each treatment

**Time Frame:** 4 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beirut

**Country:** Lebanon

**Facility:** Saint George Hospital University Medical Center

#### Overall Officials

**Official 1:**

**Affiliation:** University of Balamand/Saint George Hospital University Medical Center

**Name:** Roger N Haber, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012871

- Term: Skin Diseases

- ID: D000012877

- Term: Skin Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14396

- Name: Pruritus

- Relevance: HIGH

- As Found: Pruritus

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15680

- Name: Skin Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011537

- Term: Pruritus

### Intervention Browse Module - Ancestors

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000927

- Term: Anticonvulsants

- ID: D000014151

- Term: Anti-Anxiety Agents

- ID: D000014149

- Term: Tranquilizing Agents

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000011619

- Term: Psychotropic Drugs

- ID: D000018691

- Term: Excitatory Amino Acid Antagonists

- ID: D000018683

- Term: Excitatory Amino Acid Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018692

- Term: Antimanic Agents

- ID: D000068776

- Term: Sleep Aids, Pharmaceutical

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000000929

- Term: Antidepressive Agents, Tricyclic

- ID: D000000928

- Term: Antidepressive Agents

- ID: D000006633

- Term: Histamine Antagonists

- ID: D000018494

- Term: Histamine Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: AntiConv

- Name: Anticonvulsants

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: PsychDr

- Name: Psychotropic Drugs

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AAll

- Name: Anti-Allergic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M1694

- Name: Gabapentin

- Relevance: HIGH

- As Found: Mutation

- ID: M7491

- Name: Doxepin

- Relevance: HIGH

- As Found: Aquatic Exercise

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4246

- Name: Anticonvulsants

- Relevance: LOW

- As Found: Unknown

- ID: M16905

- Name: Anti-Anxiety Agents

- Relevance: LOW

- As Found: Unknown

- ID: M14474

- Name: Psychotropic Drugs

- Relevance: LOW

- As Found: Unknown

- ID: M20771

- Name: Excitatory Amino Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7338

- Name: Diphenhydramine

- Relevance: LOW

- As Found: Unknown

- ID: M14268

- Name: Promethazine

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4247

- Name: Antidepressive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4248

- Name: Antidepressive Agents, Tricyclic

- Relevance: LOW

- As Found: Unknown

- ID: M9709

- Name: Histamine Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9708

- Name: Histamine

- Relevance: LOW

- As Found: Unknown

- ID: M212144

- Name: Histamine phosphate

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077206

- Term: Gabapentin

- ID: D000004316

- Term: Doxepin

### Misc Info Module

- Version Holder: 2024-05-24
