PruritusPhase 4NCT01825655
Study of Using Long Acting Antihistamine to Treat Opioid Induced Itching
A Phase 4 study testing Cetirizine in people with Pruritus, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pruritus
- What is being tested?
- Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Nov 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study
Who cannot join
- Children with history of chronic urticaria
- Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
- Children with known hypersensitivity to cetirizine/zyrtec
- Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
- Children who have received Ondansetron within 24hrs prior to randomization
- Children who are on Tricyclic antidepressants
- Children who are unwilling or unable to swallow the capsule.
- Children with chronic liver or kidney disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
About this study
Official title: Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study
The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.
- Conditions
- Pruritus
- Being tested
- Cetirizine, Placebo or sugar pill
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetirizineDrug
Placebo or sugar pillDrug
| Study group | Role | What they receive |
|---|---|---|
| Cetirizine | Active comparator | zyrtec 10mg, oral, one time Receives: Drug: Cetirizine |
| Sugar pill | Placebo comparator | Placebo, one pill, one time Receives: Drug: Placebo or sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startSep 2014
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: Unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santhosh Kumar, M.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825655
- Sponsor's protocol ID
- HM20003779
- Other IDs
- IIS2012-003
- Status last verified
- Sep 2018
- First submitted
- 28 Mar 2013
- Last updated
- 10 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long Acting Antihistamine on Opioid- Induced Pruritus: A Double-blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT01825655
- Acronym / sponsor ID
- HM20003779
- Conditions
- Pruritus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 5 Apr 2013 (estimated)
- Results
- Posted 11 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is determine if long acting antihistamine like cetirizine can help with itching induced by opioid pain medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetirizine | Active comparator | Drug: Cetirizinezyrtec 10mg, oral, one time |
| Sugar pill | Placebo comparator | Drug: Placebo or sugar pillPlacebo, one pill, one time |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children age 6-18yrs on opioids who develop pruritus and are willing to participate in the study
Key exclusion criteria (8 listed)
- Children with history of chronic urticaria
- Children with other chronic pruritic condition like eczema, contact dermatitis, psoriasis
- Children with known hypersensitivity to cetirizine/zyrtec
- Children on H1 antihistamine like diphenhydramine, hydroxyzine, cetirizine, loratadine, fexofenadine, chlorpheniramine within the last 7days prior to randomization
- Children who have received Ondansetron within 24hrs prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetirizine | Drug | Cetirizine |
| Placebo or sugar pill | Drug | Sugar pill |
Primary outcome
Change in Itch Score
Time frame: Baseline to 3 hours
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pruritus
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Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
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Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santhosh Kumar, M.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cetirizine in people with Pruritus, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Itch Score (time frame: Baseline to 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2018.