Trial · NCT01062360
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
NCT01062360, Phase 3, Completed, Bayer
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine. Trials, record NCT01062360. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01062360
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
- NCT number
- NCT01062360
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,016 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Common Cold, Pharyngitis
- Interventions
- Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine, Acetylsalicylic Acid (Aspirin, BAYE4465), Pseudoephedrine, Placebo
- First posted
- 2010-02-04
- Last updated
- 2017-09-01
- Other registries' IDs
- eudract:2005-001720-36
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing | 2 hours | |
| Primary | The primary efficacy parameter for sore throat was SPID2 hours | 2 hours | |
| Secondary | The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose | 15, 30, 60, 90, 120, 240, and 360 minutes | |
| Secondary | The Nasal Congestion Score | 15, 30, 60, 90, 120, 240, and 360 minutes | |
| Secondary | The Nasal Congestion Relief Score | 15, 30, 60, 90, 120, 240, and 360 minutes | |
| Secondary | Sore throat pain relief | 15, 30, 60, 90, 120, 240, and 360 minutes | |
| Secondary | The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose | 120 minutes | |
| Secondary | The results of an overall assessment of treatment by the subjects at 120 minutes post dose | 120 minutes | |
| Secondary | The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug) | Day 3 | |
| Secondary | Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) | Day 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
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/NCT01062360
GET https://conductscience.org/api/trials/v1/NCT01062360/registered