Trial · NCT02935699
Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria
NCT02935699, Phase 3, Completed, JDP Therapeutics, Inc.; results first posted 2019-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria. Trials, record NCT02935699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02935699
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria
- NCT number
- NCT02935699
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 262 participants, actual
- Lead sponsor
- JDP Therapeutics, Inc.
- Conditions
- Acute Urticaria
- Interventions
- Test Drug (JDP-205), Active Control (Diphenhydramine)
- First posted
- 2016-10-17
- Last updated
- 2019-11-27
- Results first posted
- 2019-11-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of Patient Rated Pruritus Score | 2 hr | Change from baseline to 2 hours in patient-rated pruritus Severity score (values at 2 hours minus Baseline) Patient Pruritus Severity Score Ask the patient "How severely 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) |
| Secondary | Number of Patients Who Needed to Return to Treatment Center | up to 24 hrs | Number of patients who needed to return to treatment center approximately 24 hours after discharge |
| Secondary | Time to Discharge | up to 24 hours | Time spent (hours) at the treatment center |
| Secondary | Patient Sedation Scores | 2 hours | Patient Sedation Score at 2 hours Ask the patient "How drowsy do you feel at the moment?" 0 = None (Not drowsy at all) 1. = Mild (Slightly drowsy) 2. = Moderate (Quite drowsy) 3. = Severe (Extremely drowsy) |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of Patient Rated Pruritus Score | 2 hr | Intent To Treat population | score on a scale | MEAN |
| SECONDARY | Number of Patients Who Needed to Return to Treatment Center | up to 24 hrs | Intent To Treat Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Discharge | up to 24 hours | Intent To Treat Population | hours | MEAN |
| SECONDARY | Patient Sedation Scores | 2 hours | Intent To Treat Population | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of Patient Rated Pruritus Score | Test Drug | -1.61 | Standard Deviation 0.944 | score on a scale | |
| Change of Patient Rated Pruritus Score | Control | -1.50 | Standard Deviation 0.984 | score on a scale | |
| Number of Patients Who Needed to Return to Treatment Center | Test Drug | 7 | Participants | ||
| Number of Patients Who Needed to Return to Treatment Center | Control | 19 | Participants | ||
| Time to Discharge | Test Drug | 1.71 | Standard Deviation 0.868 | hours | |
| Time to Discharge | Control | 2.07 | Standard Deviation 1.112 | hours | |
| Patient Sedation Scores | Test Drug | 0.46 | Standard Deviation 0.721 | score on a scale | |
| Patient Sedation Scores | Control | 0.88 | Standard Deviation 0.955 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test Drug | 127 | |
| Overall Study | STARTED | Control | 135 | |
| Overall Study | COMPLETED | Test Drug | 127 | |
| Overall Study | COMPLETED | Control | 135 | |
| Overall Study | NOT COMPLETED | Test Drug | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events38
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Nervous system disorders | Test Drug | 0 | 127 | |
| other | Dizziness | Nervous system disorders | Control | 6 | 135 | |
| other | Burning sensation | Nervous system disorders | Test Drug | 0 | 127 | |
| other | Burning sensation | Nervous system disorders | Control | 2 | 135 | |
| other | Dysgeusia | Nervous system disorders | Test Drug | 1 | 127 | |
| other | Dysgeusia | Nervous system disorders | Control | 1 | 135 | |
| other | Paraesthesia | Nervous system disorders | Test Drug | 1 | 127 | |
| other | Paraesthesia | Nervous system disorders | Control | 0 | 135 | |
| other | Presyncope | Nervous system disorders | Test Drug | 1 | 127 | |
| other | Presyncope | Nervous system disorders | Control | 0 | 135 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test Drug | 0 | 127 |
| Total, all-cause mortality | Control | 0 | 135 |
| Total, other adverse events | Test Drug | 5 | 127 |
| Total, other adverse events | Control | 18 | 135 |
| Total, serious adverse events | Test Drug | 0 | 127 |
| Total, serious adverse events | Control | 1 | 135 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32653333 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Test Drug vs Control: Number of Patients Who Needed to Return to Treatment Center | Trial comparisons |
| Test Drug vs Control: deaths from any cause | Trial comparisons |
| Test Drug vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02935699
GET https://conductscience.org/api/trials/v1/NCT02935699/events?page=2