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Trial record 21 of 77 for:    Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | Pruritus

PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY UREAMIC PRURITIS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04660773
Recruitment Status : Recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Marwa Elsaeed Eldeeb, Alexandria University

Brief Summary:

Patients will be randomly assigned into 2 groups:

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

Condition or disease Intervention/treatment Phase
Refractory Uremic Pruritis Device: NB UVB phototherapy Drug: Pregabalin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NARROW BAND UVB PHOTOTHERAPY VERSUS PREGABALIN IN TREATMENT OF REFRACTORY PRURITIS IN END STAGE RENAL DISEASE PATIENTS
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
Drug Information available for: Pregabalin

Arm Intervention/treatment
Active Comparator: NB UVB phototherapy
(20 patients) will receive NB UVB phototherapy 3 sessions per week for 2 months.
Device: NB UVB phototherapy
ultraviolet phototherapy sessions

Active Comparator: pregabalin
20 patients) will receive pregabalin oral therapy (50mg after each dialysis session) for 2 months.
Drug: Pregabalin
oral medication




Primary Outcome Measures :
  1. 5 D-itching scale [ Time Frame: two month ]
    assessment of degree, duration, direction, disability and distribution of itching



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 20-60 years.
  2. 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).
  3. Refractory uremic pruritis.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04660773


Contacts
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Contact: marwa eldeeb 01200029774 marwa.eldeeb16@alexmed.edu.eg

Locations
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Egypt
Faculty of Medicine Recruiting
Alexandria, Egypt, 21521
Contact: alexandria university faculty of medicine    034862506    alexmed@edu.eg   
Sponsors and Collaborators
Alexandria University
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Responsible Party: Marwa Elsaeed Eldeeb, lecturer of dermatology, Alexandria University
ClinicalTrials.gov Identifier: NCT04660773    
Other Study ID Numbers: 0106476
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pruritus
Skin Diseases
Skin Manifestations
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs