Trial · NCT00976209
Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
NCT00976209, Phase 3, Completed, Bayer; results first posted 2011-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED). Trials, record NCT00976209. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00976209
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Consumer Preference Study of Two Formulations of Phenylephrine Hydrochloride (Study CL2008-15)(P07530)(COMPLETED)
- NCT number
- NCT00976209
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 331 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Vasomotor Rhinitis, Seasonal Allergic Rhinitis
- Interventions
- Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg, Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg
- First posted
- 2009-09-14
- Last updated
- 2015-03-11
- Results first posted
- 2011-03-25
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | Visit 6 (Period 2, Day 4) | Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were: * I preferred the relief of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the relief of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference |
| Secondary | Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | Visit 6 (Period 2, Day 4) | Convenience was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Secondary Endpoint Which product, if any, was more convenient? The possible answers were: * I preferred the convenience of Treatment A (the every 12 hours white tablet; Phenylephrine HCl 30 mg Extended Release Tablet) * I preferred the convenience of Treatment B (the every 4 hours red tablet; Phenylephrine HCl 10 mg Immediate Release tablet) or • I did not have a preference |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | Visit 6 (Period 2, Day 4) | A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | Visit 6 (Period 2, Day 4) | A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | All Participants | Phenylephrine HCL ER, 30 mg | 55 | Percentage of participants | |
| Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | All Participants | Phenylephrine HCl IR, 10 mg | 28 | Percentage of participants | |
| Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | All Participants | No Preference | 17 | Percentage of participants | |
| Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | All Participants | Phenylephrine HCL ER, 30 mg | 88 | Percentage of participants | |
| Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | All Participants | Phenylephrine HCL IR, 10 mg | 6 | Percentage of participants | |
| Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | All Participants | No Preference | 6 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | 165 | |
| Treatment Period 1 | STARTED | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | 166 | |
| Treatment Period 1 | COMPLETED | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | 162 | |
| Treatment Period 1 | COMPLETED | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | 165 | |
| Treatment Period 1 | NOT COMPLETED | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | 3 | |
| Treatment Period 1 | NOT COMPLETED | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | 1 | |
| Wash-out Period | STARTED | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | 162 | |
| Wash-out Period | STARTED | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | 165 | |
| Wash-out Period | COMPLETED | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | 158 | |
| Wash-out Period | COMPLETED | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | 163 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phenylephrine HCl ER, 30 mg | ||
| Total, all-cause mortality | Phenylephrine HCl IR, 10 mg | ||
| Total, other adverse events | Phenylephrine HCl ER, 30 mg | 0 | 327 |
| Total, other adverse events | Phenylephrine HCl IR, 10 mg | 0 | 324 |
| Total, serious adverse events | Phenylephrine HCl ER, 30 mg | 0 | 327 |
| Total, serious adverse events | Phenylephrine HCl IR, 10 mg | 0 | 324 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Phenylephrine HCl ER, 30 mg vs Phenylephrine HCl IR, 10 mg: serious adverse events |
Source 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/NCT00976209
GET https://conductscience.org/api/trials/v1/NCT00976209/registered