Trial · NCT01448057
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
NCT01448057, Phase 3, Completed, Novartis; results first posted 2017-01-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu. Trials, record NCT01448057. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01448057
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
- NCT number
- NCT01448057
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 341 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea, Sneezing
- Interventions
- Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets, Paracetamol (500 mg) tablets
- First posted
- 2011-10-07
- Last updated
- 2017-03-03
- Results first posted
- 2017-01-13
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Physician Global Evaluation of Effectiveness on Nasal Symptoms | Day 2 | The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2. Range from 1 to 5 where 1 is excellent and 5 is bad : 1 = excellent : 75% to 100% remission of signs and symptoms 5 = bad : exacerbation of nasal symptoms |
| Secondary | Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | Day 3 | Subject will assess Nasal and non Nasal symptoms using a 100 mm Visual Analog Scale for each symptom, 0=no symptoms 100= the worst possible symptoms |
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 | Physician Global Evaluation of Effectiveness on Nasal Symptoms | Day 2 | In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm | score on a scale | MEAN |
| SECONDARY | Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | Day 3 | In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm | mm | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Physician Global Evaluation of Effectiveness on Nasal Symptoms | Arm A | 1.9 | Standard Deviation 0.84 | score on a scale | |
| Physician Global Evaluation of Effectiveness on Nasal Symptoms | Arm B | 2.1 | Standard Deviation 0.91 | score on a scale | |
| Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | Arm A | 169.2 | Standard Deviation 231.14 | mm | |
| Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | Arm B | 225.3 | Standard Deviation 262.59 | mm |
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 | Combination Product | 170 | |
| Overall Study | STARTED | Paracetamol Tablets | 171 | |
| Overall Study | COMPLETED | Combination Product | 162 | |
| Overall Study | COMPLETED | Paracetamol Tablets | 167 | |
| Overall Study | NOT COMPLETED | Combination Product | 8 | |
| Overall Study | NOT COMPLETED | Paracetamol Tablets | 4 |
Source ClinicalTrials.gov
Adverse events4
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 | somnolence | Nervous system disorders | Arm A | 71 | 170 | 71 |
| other | somnolence | Nervous system disorders | Arm B | 37 | 171 | 37 |
| other | Abdominal pain | Gastrointestinal disorders | Arm A | 6 | 170 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Arm B | 2 | 171 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A | ||
| Total, all-cause mortality | Arm B | ||
| Total, other adverse events | Arm A | 77 | 170 |
| Total, other adverse events | Arm B | 39 | 171 |
| Total, serious adverse events | Arm A | 0 | 170 |
| Total, serious adverse events | Arm B | 0 | 171 |
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 |
|---|
| Arm A vs Arm B: 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/NCT01448057
GET https://conductscience.org/api/trials/v1/NCT01448057/registered