Nasal Congestion, Rhinorrhea, Sneezing, Upper Respiratory Tract Infection
Conditions
Keywords
Paracetamol, dimethindene maleate, phenylephrine hydrochloride, cold and flu symptoms
Brief summary
The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
Interventions
DRUGParacetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg) tablets
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: • acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea. *
Exclusion criteria
* Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer. * History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A Combination Product
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets | 170 |
| Arm B Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets | 171 |
| Total | 341 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Arm B | Arm A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 171 Participants | 170 Participants | 341 Participants |
| Age, Continuous | 34.5 years STANDARD_DEVIATION 11.76 | 36 years STANDARD_DEVIATION 11.64 | 35.3 years STANDARD_DEVIATION 11.71 |
| Gender Female | 134 Participants | 122 Participants | 256 Participants |
| Gender Male | 37 Participants | 48 Participants | 85 Participants |
| Region of Enrollment Brazil | 171 participants | 170 participants | 341 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 77 / 170 | 39 / 171 |
| serious Total, serious adverse events | 0 / 170 | 0 / 171 |
Outcome results
Primary
Physician Global Evaluation of Effectiveness on Nasal Symptoms
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
Time frame: Day 2
Population: In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Physician Global Evaluation of Effectiveness on Nasal Symptoms | 1.9 score on a scale | Standard Deviation 0.84 |
| Arm B | Physician Global Evaluation of Effectiveness on Nasal Symptoms | 2.1 score on a scale | Standard Deviation 0.91 |
Secondary
Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms
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
Time frame: Day 3
Population: In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A | Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | 169.2 mm | Standard Deviation 231.14 |
| Arm B | Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms | 225.3 mm | Standard Deviation 262.59 |