Trial Outcomes & Findings for Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching (NCT NCT01825655)

NCT ID: NCT01825655

Last Updated: 2018-10-10

Results Overview

Itch score will be used to analyze our primary outcome. The subjects will have an itch score at baseline and compared to itch score at 3hrs post intervention. Itch score is measured on a scale of 1 to 4, with lower scores indicating less itchiness.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: Baseline to 3 hours
• Results posted on: 2018-10-10

Participant Flow

One other patient consented but did not qualify to begin the study.

Participant milestones

Measure	Cetirizine zyrtec 10mg, oral, one time Cetirizine	Sugar Pill Placebo, one pill, one time Placebo or sugar pill
Overall Study STARTED	0	2
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching

Baseline characteristics by cohort

Measure	Cetirizine zyrtec 10mg, oral, one time Cetirizine	Sugar Pill n=2 Participants Placebo, one pill, one time Placebo or sugar pill	Total n=2 Participants Total of all reporting groups
Age, Customized Between 6 and 21 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 hours

Population: No participants were randomized into the cetirizine arm

Itch score will be used to analyze our primary outcome. The subjects will have an itch score at baseline and compared to itch score at 3hrs post intervention. Itch score is measured on a scale of 1 to 4, with lower scores indicating less itchiness.

Outcome measures

Measure	Cetirizine zyrtec 10mg, oral, one time Cetirizine	Sugar Pill n=2 Participants Placebo, one pill, one time Placebo or sugar pill
Change in Itch Score	—	1.5 units on a scale Interval 1.0 to 2.0

Adverse Events

Cetirizine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Santhosh Kumar, MD

Virginia Commonwealth University

Phone: 804-628-1605

Email: santhosh.kumar@vcuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place