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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Product | Experimental | Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets |
|
| Paracetamol tablets | Active Comparator | Paracetamol (500 mg) tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets | Drug | Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 3 |
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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:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia | Belo Horizonte/MG | 30150-221 | Brazil | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Paracetamol (500 mg) tablets | Drug | Paracetamol (500 mg) tablets |
|
| Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades |
| Campinas/SP |
| Brazil |
| Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres - | Fortaleza/CE | 60170-320 | Brazil |
| Polonio Clinica De Servicios Medicos EM Gastroenterologia E Cirurgia Toracica S/S LTDA - ME, Rua Major Alfredo Servulo de Oliveira Romao, 103, Chacara Braz Miraglia | Jau/SP | 17210-070 | Brazil |
| : Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos | São Paulo | 13271-130 | Brazil |
| Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino | São Paulo | Brazil |
| Paracetamol Tablets |
Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arm B | Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm | Posted | Mean | Standard Deviation | score on a scale | Day 2 |
|
|
| ||||||||||||||||||||||||||||
| 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 | In the combination product arm 11 subjects had missing assessment and 5 subject in the paracetamol arm | Posted | Mean | Standard Deviation | mm | Day 3 |
|
|
3 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 170 | 77 | 170 | ||
| EG001 | Arm B | Paracetamol (500 mg) tablets Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets | 0 | 171 | 39 | 171 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
Preliminary agreement between Novartis Consumer Health and the investigator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical research Respiratory | Novartis consumer Health a GSK Consumer Healtcare company | (1) 5512065988 | anna.x.grinienko@gsk.com |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D015508 | Nasal Obstruction |
| D000086722 | Rhinorrhea |
| D012912 | Sneezing |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D004115 | Dimethindene |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| >=65 years |
|
| Male |
|
|