PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY... | NCT04660773

Studies
PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

NCT04660773

Sponsor

Alexandria University

Status

Unknown status

Last Update Posted

Jul 26, 2021Actual

Enrollment

40Estimated

Phase

Phase 2

Conditions

Refractory Uremic Pruritis

Interventions

NB UVB phototherapy
Pregabalin

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2021Estimated

Primary Completion Date

Mar 1, 2022Estimated

Completion Date

Mar 1, 2022Estimated

First Submitted Date

Dec 3, 2020

First Submission Date that Met QC Criteria

Dec 3, 2020

First Posted Date

Dec 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2021

Last Update Posted Date

Jul 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NB UVB phototherapy	Device	ultraviolet phototherapy sessions	NB UVB phototherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
5 D-itching scale	assessment of degree, duration, direction, disability and distribution of itching	two month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
marwa eldeeb	Contact	01200029774		marwa.eldeeb16@alexmed.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine	Recruiting	Alexandria		21521	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069583	Pregabalin

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided