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PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Primary Purpose

Refractory Uremic Pruritis

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

NB UVB phototherapy

Pregabalin

About this trial

This is an interventional treatment trial for Refractory Uremic Pruritis

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

NB UVB phototherapy

pregabalin

Arm Description

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

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

Outcomes

Primary Outcome Measures

5 D-itching scale

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04660773

First Posted

December 3, 2020

Last Updated

July 23, 2021

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04660773

Brief Title

PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

Official Title

NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2021 (Anticipated)

Primary Completion Date

March 1, 2022 (Anticipated)

Study Completion Date

March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Refractory Uremic Pruritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NB UVB phototherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

pregabalin

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

NB UVB phototherapy

Intervention Description

ultraviolet phototherapy sessions

Intervention Type

Drug

Intervention Name(s)

Pregabalin

Intervention Description

oral medication

Primary Outcome Measure Information:

Title

5 D-itching scale

Description

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

Time Frame

two month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

marwa eldeeb

Phone

01200029774

marwa.eldeeb16@alexmed.edu.eg

Facility Information:

Facility Name

Faculty of Medicine

City

Alexandria

ZIP/Postal Code

21521

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

alexandria university faculty of medicine

Phone

034862506

alexmed@edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

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