Clinical Trials Logo
  1. Home
  2. Burns
  3. NCT02975271
  4. Details
NCT02975271 Clinical Trial

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Burns Clinical Trial

— AUBURN  

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02975271
Other study ID # MTI-104
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 2016
Est. completion date January 17, 2017

Study information
Verified date May 2021
Source Vyne Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury

Recruitment information / eligibility
Status Terminated
Enrollment 1
Est. completion date January 17, 2017
Est. primary completion date January 17, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Key Inclusion Criteria: - Male or female, age 18-65 years at consent. - History of serious burn injury - Pruritus (itchiness) prior to the initial screening visit and during the screening period - Judged to be in good health in the investigator's opinion. Key Exclusion Criteria: - Prior treatment with study drug or similar drug - Pruritus (itchiness) due to another reason besides burn injury/ healing. - Presence of any medical condition or disability that, in the investigator's opinion, could interfere with the assessment of safety or efficacy in this trial or compromise the safety of the subject. - History of hypersensitivity to study drug or any of its components. - Currently pregnant or male partner of pregnant female. - Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Serlopitant

• Placebo
Matching placebo

Locations
Country Name City State
United States Study Site 412 Gainesville Florida
United States Study Site 409 Lincoln Nebraska
United States Study Site 404 Phoenix Arizona
United States Study Site 413 Seattle Washington
United States Study Site 403 Tampa Florida
United States Study Site 402 Washington District of Columbia
United States Study Site 401 Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Vyne Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Itch Intensity - Numeric Rating Scale Week 6
Secondary Itch Intensity Responder Rate - Numeric Rating Scale Week 6
See also
  Status Clinical Trial Phase
Completed NCT05023135 - DeepView SnapShot Portable (DV-SSP): Device Training Study
Completed NCT05276869 - Reliability and Feasibility of WeeFIM Instrument to Measure Functional Independence in Pediatric Burns
Completed NCT04548635 - VR for Burn Dressing Changes at Home Phase 2/Phase 3
Not yet recruiting NCT06076031 - Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing N/A
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT03113253 - TRANexamic Acid to Reduce Bleeding in BURN Surgery Phase 4
Recruiting NCT04090424 - Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03159182 - Study of Silicone Material Inserts To Treat Burn Scars N/A
Recruiting NCT02904941 - Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns N/A
Completed NCT02681757 - Comparison of Mepitel Ag vs Antibiotic Ointment Used With Soft Cast Technique for Treatment of Pediatric Burns N/A
Recruiting NCT01812941 - Evaluation of Mitochondrial Dysfunction in Severe Burn and Trauma Patients N/A
Completed NCT01437852 - StrataGraft® Skin Tissue as an Alternative to Autografting Deep Partial-Thickness Burns Phase 1
Completed NCT01214811 - Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing Phase 3
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Terminated NCT00822796 - Thermogard™ Efficacy Trial N/A
Terminated NCT00634166 - Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group Phase 4
Terminated NCT00824681 - Effect of Music Therapy on Families of Burn Patients Phase 1
Terminated NCT00464386 - Continuous Glucose Monitoring (POC) in the ICU N/A
Withdrawn NCT00216983 - Proline Metabolism in Severely Burned Patients: Effect of Modulated Parenteral Feeding N/A