Trial · NCT03339726
Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
NCT03339726, Phase 2, Terminated, Johnson & Johnson Consumer Inc. (J&JCI); results first posted 2019-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold. Trials, record NCT03339726. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03339726
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized, Double-blind, Placebo-Controlled, Efficacy Study of a New Formulation of Phenylephrine HCL in the Common Cold
- NCT number
- NCT03339726
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 193 participants, actual
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Conditions
- Common Cold
- Interventions
- New Formulation Phenylephrine HCl, Marketed Phenylephrine HCl, Placebo
- First posted
- 2017-11-13
- Last updated
- 2019-06-04
- Results first posted
- 2019-06-04
- Limitations and caveats
An interim statistical analysis was conducted after the study failed to meet planned enrollment in the 2017-2018 cold season. The study was subsequently cancelled and enrollment was discontinued. Analysis of the 193 enrolled subjects was conducted.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline in the Nasal Congestion Severity Score | 0-12 hours | Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. |
| Secondary | Average Change From Baseline in the Nasal Congestion Severity Score | 0-12 hours | Average change from baseline in the Nasal Congestion Severity Score averaged over hours 8-12. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-2 hours | Change from baseline in the Nasal Congestion Severity Score at 2 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-4 hours | Change from baseline in the Nasal Congestion Severity Score at 4 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-6 hours | Change from baseline in the Nasal Congestion Severity Score at 6 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-8 hours | Change from baseline in the Nasal Congestion Severity Score at 8 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-10 hours | Change from baseline in the Nasal Congestion Severity Score at 10 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-12 hours | Change from baseline in the Nasal Congestion Severity Score at 12 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Change From Baseline in the Nasal Congestion Severity Score | 0-24 hours | Change from baseline in the Nasal Congestion Severity Score at 24 hours. This is an 8 point scale with 0=None and 7=Severe. |
| Secondary | Average Change From Baseline in Sinus Pressure/Tenderness Scores | 0-12 hours | Change from baseline in Sinus Pressure/Tenderness Scores averaged over assessments at 2, 4, 6, 8, 10, and 12 hours. This is an 8 point scale with 0=None and 7=Severe. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline in the Nasal Congestion Severity Score | 0-12 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Average Change From Baseline in the Nasal Congestion Severity Score | 0-12 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-2 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-4 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-6 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-8 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-10 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-12 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in the Nasal Congestion Severity Score | 0-24 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
| SECONDARY | Average Change From Baseline in Sinus Pressure/Tenderness Scores | 0-12 hours | Analysis is based on the Full Analysis Set population, which included all participants who were randomized and provided a valid baseline assessment of nasal congestion severity. | units on a scale | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group51
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline in the Nasal Congestion Severity Score | Placebo | 1.80 | Standard Error 0.156 | units on a scale | |
| Mean Change From Baseline in the Nasal Congestion Severity Score | PE-IR | 2.03 | Standard Error 0.154 | units on a scale | |
| Mean Change From Baseline in the Nasal Congestion Severity Score | PE-ER | 1.93 | Standard Error 0.158 | units on a scale | |
| Average Change From Baseline in the Nasal Congestion Severity Score | Placebo | 2.14 | Standard Error 0.185 | units on a scale | |
| Average Change From Baseline in the Nasal Congestion Severity Score | PE-IR | 2.39 | Standard Error 0.182 | units on a scale | |
| Average Change From Baseline in the Nasal Congestion Severity Score | PE-ER | 2.16 | Standard Error 0.187 | units on a scale | |
| Change From Baseline in the Nasal Congestion Severity Score | Placebo | 1.12 | Standard Error 0.163 | units on a scale | |
| Change From Baseline in the Nasal Congestion Severity Score | PE-IR | 1.24 | Standard Error 0.161 | units on a scale | |
| Change From Baseline in the Nasal Congestion Severity Score | PE-ER | 1.52 | Standard Error 0.165 | units on a scale | |
| Change From Baseline in the Nasal Congestion Severity Score | Placebo | 1.69 | Standard Error 0.193 | units on a scale |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | STARTED | PE-IR | 66 | |
| Overall Study | STARTED | PE-ER | 63 | |
| Overall Study | COMPLETED | Placebo | 63 | |
| Overall Study | COMPLETED | PE-IR | 65 | |
| Overall Study | COMPLETED | PE-ER | 63 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | PE-IR | 1 | |
| Overall Study | NOT COMPLETED | PE-ER | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 64 |
| Total, all-cause mortality | PE-IR | 0 | 66 |
| Total, all-cause mortality | PE-ER | 0 | 63 |
| Total, other adverse events | Placebo | 0 | 64 |
| Total, other adverse events | PE-IR | 0 | 66 |
| Total, other adverse events | PE-ER | 0 | 63 |
| Total, serious adverse events | Placebo | 0 | 64 |
| Total, serious adverse events | PE-IR | 0 | 66 |
| Total, serious adverse events | PE-ER | 0 | 63 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03339726
GET https://conductscience.org/api/trials/v1/NCT03339726/results?page=2