Acute UrticariaPhase 3NCT02023164
Pilot Phase III Clinical Trial of JDP-205 IV Injection for Treatment of Acute Urticaria
A Phase 3 study testing JDP-205 Injection and Diphenhydramine in people with Acute Urticaria, run by JDP Therapeutics, Inc. at 6 sites in 2 countries.
Trial summary
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Urticaria
- What is being tested?
- JDP-205 Injection and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jul 2013to Dec 2014
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with a diagnosis of acute urticaria associated with an acute allergic reaction to a known (e.g. food, medication, insect bites) or unknown allergen who need treatment with an injectable antihistamine to alleviate their symptoms;
- 18 years of age or older;
- Be willing and able to give informed consent;
- Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the investigator);
- Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the investigator).
Who cannot join
- Receipt of an investigational drug or device, within the past 30 days;
- Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
- Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
- Receipt of any antihistamine (H1 antagonist) within the past 4 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
- Receipt of an H2 antagonist within the past 12 hours;
- Receipt of doxepin within the past 48 hours; doxepin is an antidepressant, but it also has antihistamine properties;
Show all 18Show fewer
- Receipt of steroids by the oral, IV, IM, or inhalational routes route within the past 48 hours to manage an acute allergic reaction;
- Receipt of epinephrine (EpiPen or any other brand) within the past 1 hour;
- Has known allergy to hydroxyzine, cetirizine or levocetirizine, or diphenhydramine;
- Pregnancy or breastfeeding;
- Patients who require epinephrine immediately to manage their acute allergic symptoms;
- Patients who have an acute reaction to medication they are taking (e.g. antibiotics, ACE inhibitors, NSAIDs) and who cannot stop the medication;
- Patients who, based on their medical history or in the opinion of the investigator, have chronic idiopathic urticaria, hereditary angioedema, urticaria refractory to antihistamines, or dermatological disease that interferes with evaluation of a therapeutic response;
- Urticaria not associated with an acute allergic reaction;
- Any condition that in the view of the investigator makes the subject unsuitable for enrollment in this study;
- History of HIV or other known immunodeficiency;
- Major medical or psychiatric illness, other than acute urticaria, at the time of presentation;
- Inability to provide informed consent.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada4 sites
Glengarry Memorial Hospital, Independent Practice
Alexandria, Ontario
Del Carpio Independent Practice
Montreal, Quebec, H3G 1L5
Ottawa Hospital, Civic Campus
Ottawa, Ontario
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
United States2 sites
University of Cincinnati, Department of Emergency Medicine
Cincinnati, Ohio, 45267-0769
OSU Hospitals, Department of Emergency Medicine
Columbus, Ohio, 43210
About this study
Official title: Multicenter Pilot Study to Assess the Feasibility of Conducting Phase III Trial Comparing IV Cetirizine Injection, 10 mg, to IV Diphenhydramine, 50 mg, for The Treatment of Acute Urticaria
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.
Read the detailed description
Multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics. This study will be conducted in 33 patient who either present themselves to the hospital emergency department, allergy clinic or urgent care centers with acute urticaria or developed acute urticaria following a allergen challenge at an allergy clinic.
Following informed consent, eligibility will be established, capturing baseline data including vitals, age, medical history, and medications taken prior to coming to the clinical study site. Following data collection, study subjects will be randomized in a 1:1 ratio to receive study drug of either cetirizine 10 mg IV or diphenhydramine, 50 mg IV. Baseline data including vital signs, the extent of urticaria and erythema, the severity of pruritus, and the level of sedation will be recorded prior to and at 1 hour and 2 hours post study drug administration, and at the time of "Readiness for Discharge". The actual time at which the investigator determines that the subject is ready for discharge (physically and mentally fit) from the study site will also be recorded. At these same time intervals, subjects will be asked to self-rate (recorded by study staff) severity of their pruritus and level of sedation (recorded by study staff).
Twenty-four hours following discharge from the study site, study staff will call the subject to ask them a few short questions to follow-up on the treatment of their acute urticaria. All adverse and serious adverse events experienced by the subjects following informed consent, and all data captured will be recorded in the source documents and/or case report forms.
- Conditions
- Acute Urticaria
- Being tested
- JDP-205 Injection, Diphenhydramine
- Keywords
- urticaria, allergic reaction, cetirizine, JDP-205
- Medical subject headings
- Urticaria, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDP-205 InjectionDrug
Also called Cetirizine, Quzyttir
Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
DiphenhydramineDrug
Also called Benadryl, DPH
Diphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
| Study group | Role | What they receive |
|---|---|---|
| Test Drug | Experimental | JDP-205 Injection, 10 mg/mL, 1 mL Receives: Drug: JDP-205 Injection |
| Control | Active comparator | Diphenhydramine Injection, 50 mg/mL, 1 mL Receives: Drug: Diphenhydramine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of Urticaria/Erythema Score (Physician Assessment)
Extent of Urticaria/Erythema Score (Physician Assessment), capturing extent of urticaria/erythema, using the Body Chart (adopted from Burn Chart).
Extent of Urticaria/Erythema Score is the average of the 2 scores:
- Percentage of body area using the body chart (adopted from burn Chart) 0 = none, 1= mild (,25% body coverage), 2 = moderate (25-50% body coverage, 3 = Severe/intense .50% body coverage
- Intensity of redness (adopted from PASI) 0 = none, 1 = mile (light pink) 2= moderate (pink), 3 =severe/intense (red)
Measured: Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)
Physician Pruritus Severity Score
Physician Pruritus Severity Score based on patient expression of severity of itchiness.
0= none
1 = Mild (patient expresses itchiness but tolerable, and does not scratch 2= moderate definite awareness, bothersome, intermittently scratch affected area 3= severe difficult to tolerate scratch vigorously
Measured: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Patient Pruritis Severity Score
Patient Pruritis Severity Score based on severity of itching at time of assessment.
How severly are your hives itching at the moment? 0 = none
1= mild minimal awareness easily tolerated 2 = moderate definite awareness quite bothersome 3= severe difficult to tolerate
Measured: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Composite Acute Urticaria Score Change From Baseline
A composite acute urticaria score, the sum of Extent of urticaria/erythema score (Physician), Physician pruritis score and Patient pruritis severity score. A composite acute urticaria score which the sum of the above three parameters (i.e. 0-9) was calculated post hoc for each patient at each time point and then their score change from the baseline were compared between the two treatment groups. Higher values indicate a worse outcome.
Measured: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
Secondary outcomes (3)
Sedation Scores and Time to Readiness for Discharge
Time from study drug injection to time to readiness for discharge based on composite sedation score at readiness for discharge consist of Physician Sedation Score and Patient Sedation Score
Physician Sedation Score
Score ranged from 0 to 4 (0=min, 4=max)
0 = None (Patient is completely alert. Does not look tired at all), 1 = Mild (Patient sitting/lying comfortably, and looks tired), 2 = Moderate (Drowsy, with occasional eyes closing), 3 = Severe (Asleep, with eyes closed but responds to minor motor stimulation), 4 = Extremely Severe (Asleep; does not respond to minor motor stimulation)
Patient Sedation Score
Score ranged from 0 to 4 (0=min, 4=max)
0 = None (Not drowsy at all), 1 = Mild (Slightly drowsy), 2 = Moderate (Quite drowsy), 3 = Severe (Extremely drowsy), 4 = Extremely Severe (Asleep, cannot self-rate)
Higher the sedation score = worse outcome
A composite sedation score which is the sum of the two parameters.
Measured: Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.
Percentage of Patients Requiring Additional Medication
Percentage of Patients Requiring Additional Medication (Rescue Medication)
Measured: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
Sedation Scores and Time to Readiness for Discharge HH:MM
Time from study drug injection to time to readiness for discharge based on Physician and Patient Sedation Scores
Physician Sedation Score:
0 = None
1 = Mild 2 = Moderate 3= Severe 4 = Extremely Severe Patient Sedation Score 0= None
1- Mild 2 = Moderate 3= Severe 4 = Extremely Severe Higher scores = worse outcome
Measured: Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Acute UrticariaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- JDP Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janine North, B.S., Study director, TerSera Therapeutics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023164
- Sponsor's protocol ID
- ETTAU-02
- Other IDs
- CTN-P4-427
- Status last verified
- Feb 2024
- First submitted
- 18 Dec 2013
- Last updated
- 9 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot Study to Assess the Feasibility of Conducting Phase III Trial Comparing IV Cetirizine Injection, 10 mg, to IV Diphenhydramine, 50 mg, for The Treatment of Acute Urticaria
- ClinicalTrials.gov ID
- NCT02023164
- Acronym / sponsor ID
- ETTAU-02
- Conditions
- Acute Urticaria
- Keywords
- urticaria, allergic reaction, cetirizine, JDP-205
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- JDP Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 9 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics.
Detailed description
Multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL (Benadryl or generic equivalent), in approximately 36 patients with acute urticaria requiring treatment in Hospital Emergency Departments, Urgent Care Centers and Allergy Clinics. This study will be conducted in 33 patient who either present themselves to the hospital emergency department, allergy clinic or urgent care centers with acute urticaria or developed acute urticaria following a allergen challenge at an allergy clinic.
Following informed consent, eligibility will be established, capturing baseline data including vitals, age, medical history, and medications taken prior to coming to the clinical study site. Following data collection, study subjects will be randomized in a 1:1 ratio to receive study drug of either cetirizine 10 mg IV or diphenhydramine, 50 mg IV. Baseline data including vital signs, the extent of urticaria and erythema, the severity of pruritus, and the level of sedation will be recorded prior to and at 1 hour and 2 hours post study drug administration, and at the time of "Readiness for Discharge". The actual time at which the investigator determines that the subject is ready for discharge (physically and mentally fit) from the study site will also be recorded. At these same time intervals, subjects will be asked to self-rate (recorded by study staff) severity of their pruritus and level of sedation (recorded by study staff).
Twenty-four hours following discharge from the study site, study staff will call the subject to ask them a few short questions to follow-up on the treatment of their acute urticaria. All adverse and serious adverse events experienced by the subjects following informed consent, and all data captured will be recorded in the source documents and/or case report forms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Drug | Experimental | Drug: JDP-205 InjectionJDP-205 Injection, 10 mg/mL, 1 mL |
| Control | Active comparator | Drug: DiphenhydramineDiphenhydramine Injection, 50 mg/mL, 1 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients with a diagnosis of acute urticaria associated with an acute allergic reaction to a known (e.g. food, medication, insect bites) or unknown allergen who need treatment with an injectable antihistamine to alleviate their symptoms;
- 18 years of age or older;
- Be willing and able to give informed consent;
- Patients with a Physician Pruritus Severity Score ≥ 1 (determined by the investigator);
- Patients with an Extent of Urticaria/Erythema Score ≥ 1 (determined by the investigator).
Key exclusion criteria (18 listed)
- Receipt of an investigational drug or device, within the past 30 days;
- Patients in whom an antihistamine may be contraindicated (e.g. narrow angle glaucoma, symptomatic prostatic hypertrophy);
- Patients who, in the opinion of the investigator, may not tolerate an IV injection of diphenhydramine 50 mg, or cetirizine 10 mg;
- Receipt of any antihistamine (H1 antagonist) within the past 4 hours regardless of the route of administration, e.g. diphenhydramine, cetirizine, loratadine, fexofenadine, levocetirizine, desloratadine;
- Receipt of an H2 antagonist within the past 12 hours;
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 |
|---|---|---|
| JDP-205 InjectionAlso: Cetirizine, QuzyttirCetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes | Drug | Test Drug |
| DiphenhydramineAlso: Benadryl, DPHDiphenhydramine Injection, 50 mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes | Drug | Control |
Primary outcome
Extent of Urticaria/Erythema Score (Physician Assessment)
Time frame: Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)
Extent of Urticaria/Erythema Score (Physician Assessment), capturing extent of urticaria/erythema, using the Body Chart (adopted from Burn Chart). Extent of Urticaria/Erythema Score is the average of the 2 scores: 1. Percentage of body area using the body chart (adopted from burn Chart) 0 = none, 1= mild (,25% body coverage), 2 = moderate (25-50% body coverage, 3 = Severe/intense .50% body coverage 2. Intensity of redness (adopted from PASI) 0 = none, 1 = mile (light pink) 2= moderate (pink), 3 =severe/intense (red)
Physician Pruritus Severity Score
Time frame: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Physician Pruritus Severity Score based on patient expression of severity of itchiness. 0= none 1 = Mild (patient expresses itchiness but tolerable, and does not scratch 2= moderate definite awareness, bothersome, intermittently scratch affected area 3= severe difficult to tolerate scratch vigorously
Patient Pruritis Severity Score
Time frame: Baseline, 1 hour, 2 hour, discharge or up to 4 hours post intervention, whichever came first
Patient Pruritis Severity Score based on severity of itching at time of assessment. How severly are your hives itching at the moment? 0 = none 1= mild minimal awareness easily tolerated 2 = moderate definite awareness quite bothersome 3= severe difficult to tolerate
Composite Acute Urticaria Score Change From Baseline
Time frame: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
A composite acute urticaria score, the sum of Extent of urticaria/erythema score (Physician), Physician pruritis score and Patient pruritis severity score. A composite acute urticaria score which the sum of the above three parameters (i.e. 0-9) was calculated post hoc for each patient at each time point and then their score change from the baseline were compared between the two treatment groups. Higher values indicate a worse outcome.
3 secondary outcomes
Sedation Scores and Time to Readiness for Discharge
Time frame: Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.
Percentage of Patients Requiring Additional Medication
Time frame: Baseline, 1 hour, 2 hour, Discharge (an average of 1 day)
Sedation Scores and Time to Readiness for Discharge HH:MM
Time frame: Assessed at discharge or up to 4 hours post intervention, whichever came first data at discharge reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Acute Urticaria
Recruiting
Comparing Standard-Dose and High-Dose Cetirizine for Acute Urticaria
Acute Urticaria
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
RecruitingPhase 2
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN)
Enrolling by invitationPhase 2/3
Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema
Hereditary Angioedema, Hereditary Angioedema Type I
RecruitingPhase 1/2
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
Hereditary Angioedema (HAE), Angioedema
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.
Janine North, B.S. study director
TerSera Therapeutics LLC
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JDP-205 Injection and Diphenhydramine in people with Acute Urticaria, run by JDP Therapeutics, Inc. at 6 sites in 2 countries.
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 5 inclusion and 18 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: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 9 Feb 2024). 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?
Extent of Urticaria/Erythema Score (Physician Assessment) (time frame: Baseline, 1 hour, 2 hour, Discharge (up to 4 hours)). The study lists 4 primary outcomes in all. 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 9 Feb 2024.