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| ID | Type | Description | Link |
|---|---|---|---|
| IIS2012-003 | Other Identifier | Virginia Commonwealth University |
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Unable to recruit patients
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The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetirizine | Active Comparator | zyrtec 10mg, oral, one time |
|
| Sugar pill | Placebo Comparator | Placebo, one pill, one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetirizine | Drug |
| ||
| Placebo or sugar pill |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Itch Score | 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. | Baseline to 3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santhosh Kumar, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23298 | United States |
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One other patient consented but did not qualify to begin the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetirizine | zyrtec 10mg, oral, one time Cetirizine |
| FG001 | Sugar Pill | Placebo, one pill, one time Placebo or sugar pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No participants were randomized to the cetirizine group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cetirizine | zyrtec 10mg, oral, one time Cetirizine |
| BG001 | Sugar Pill | Placebo, one pill, one time Placebo or sugar pill |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Itch Score | 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. | No participants were randomized into the cetirizine arm | Posted | Mean | Full Range | units on a scale | Baseline to 3 hours |
|
12 hours
No participants randomized to Cetirizine arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cetirizine | zyrtec 10mg, oral, one time Cetirizine | 0 |
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The study had to prematurely end due to difficulty in recruiting subjects. The sample size is not large enough to do any statistical analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Santhosh Kumar, MD | Virginia Commonwealth University | 804-628-1605 | santhosh.kumar@vcuhealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2015 | Aug 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sugar Pill | Placebo, one pill, one time Placebo or sugar pill | 0 | 2 | 0 | 2 | 0 | 2 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |