Phase 3
Completed N=240
Effects of Two Doses of a Common Cold Treatment on Alertness
Source: ClinicalTrials.gov NCT01686646 ↗Enrolled (actual)
240
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test — 8.3; 4.8; 4.5; 2.7 Correct responses — p=0.0248
Summary
This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Number of Accurate Responses to Rapid Visual Information Processing (RVIP) Cognitive Test |
8.3; 4.8; 4.5; 2.7 | 0.0248 sig |
| SECONDARY Change From Baseline in Number of Accurate Responses to RVIP Cognitive Test |
7.3; 4.4; 6.2; 3.5 | 0.0696 |
| SECONDARY Change From Baseline in Mean Time of Accurate Responses to RVIP Cognitive Task |
-1.4; 2.4; -0.9; -9.9; -10.3; -6.0 | — |
| SECONDARY Change From Baseline in Number of Inaccurate and Missed Responses to RVIP Cognitive Task |
-5.7; -2.8; 1.4; -2.4; -4.5; -1.7 | — |
| SECONDARY Change From Baseline in Number of Accurate Responses to Sustained Attention Tasks (SAT) Cognitive Test |
1.0; 0.5; 2.0; 0.0; 2.0; 1.0 | — |
| SECONDARY Change From Baseline in Mean Time of Accurate Responses to SAT Cognitive Task |
-16.7; -9.8; -10.8; -12.0; -21.2; -10.4 | — |
| SECONDARY Change From Baseline in Number of Incorrect and Missed Responses to SAT Cognitive Test |
-4.6; -1.1; -4.2; -1.6; -4.4; -2.3 | — |
| SECONDARY Change From Baseline in Number of Valid Responses to Divided Attention Task (DAT) Cognitive Test |
10.0; 6.0; 8.0; 5.5; 11.0; 6.0 | — |
| SECONDARY Change From Baseline in Mean Time of Accurate Responses to DAT Cognitive Test |
-3.0; 1.5; -4.4; -2.2; -11.0; -5.3 | — |
| SECONDARY Change From Baseline in Number of Incorrect and Missed Responses to DAT Cognitive Test |
-6.5; -4.2; -5.4; -3.3; -7.1; -4.9 | — |
Eligibility Criteria
- Participants with symptoms of cold < 96 hours, rating of at least '2' on malaise at least 4 other symptoms of cold.
- No history of clinically significant perennial rhinitis, no recent antibiotic, antihistamine or cold treatment, no caffeine in the previous 12 hours, no psychoactive medication in the 14 days prior to screening, no pregnancy, breastfeeding or participation in this trial, or another trial in the 30 days prior to screening.
Data sourced from ClinicalTrials.gov (NCT01686646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.