Study Stopped
Business Reasons
Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
AUBURN
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Pruritus Following Burn Injury
1 other identifier
interventional
1
1 country
7
Brief Summary
Study of the Efficacy, Safety \& Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2016
Shorter than P25 for phase_2
7 active sites
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
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2017
CompletedMay 20, 2021
May 1, 2021
3 months
November 22, 2016
May 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Itch Intensity - Numeric Rating Scale
Week 6
Secondary Outcomes (1)
Itch Intensity Responder Rate - Numeric Rating Scale
Week 6
Study Arms (2)
Serlopitant
EXPERIMENTALDose of experimental drug Serlopitant
Placebo
PLACEBO COMPARATORMatching dose of Placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Study Site 404
Phoenix, Arizona, United States
Study Site 402
Washington D.C., District of Columbia, United States
Study Site 412
Gainesville, Florida, United States
Study Site 403
Tampa, Florida, United States
Study Site 409
Lincoln, Nebraska, United States
Study Site 401
Winston-Salem, North Carolina, United States
Study Site 413
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 29, 2016
Study Start
November 1, 2016
Primary Completion
January 17, 2017
Study Completion
January 17, 2017
Last Updated
May 20, 2021
Record last verified: 2021-05