NCT04660773

Brief Summary

Patients will be randomly assigned into 2 groups:

  1. 1.Group A: (20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
  2. 2.Group B: (20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

7 months

First QC Date

December 3, 2020

Last Update Submit

July 23, 2021

Conditions

Refractory Uremic Pruritis

Outcome Measures

Primary Outcomes (1)

  • 5 D-itching scale

    assessment of degree, duration, direction, disability and distribution of itching

    two month

Study Arms (2)

NB UVB phototherapy

ACTIVE COMPARATOR

(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.

Device: NB UVB phototherapy

pregabalin

ACTIVE COMPARATOR

20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.

Drug: Pregabalin

Interventions

NB UVB phototherapyDEVICE

ultraviolet phototherapy sessions

NB UVB phototherapy
PregabalinDRUG

oral medication

pregabalin

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 20-60 years.
  • End stage renal disease (the last stage(stage 5) of chronic disease which means kidneys are only functioning at 10 to 15 percent of their normal capacity and dialysis or kidney transplant is necessary to stay alive).
  • Refractory uremic pruritis.

You may not qualify if:

  • Other causes of pruritis (Dermatological or systemic) e.g. atopic, cholestatic liver disease.
  • Photosensitivity.
  • Contraindication or allergy to pregabalin.
  • Patients on antipruritic drugs e.g. antihistamines, steroids, emollients, opioid agonists.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Alexandria, 21521, Egypt

RECRUITING

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

marwa eldeeb

CONTACT

01200029774marwa.eldeeb16@alexmed.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of dermatology

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 9, 2020

Study Start

August 1, 2021

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)