Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
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ClinicalTrials.gov Identifier: NCT01448057 |
Recruitment Status :
Completed
First Posted : October 7, 2011
Results First Posted : January 13, 2017
Last Update Posted : March 3, 2017
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Condition or disease | Intervention/treatment | Phase |
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Upper Respiratory Tract Infection Nasal Congestion Rhinorrhea Sneezing | Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets Drug: Paracetamol (500 mg) tablets | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 341 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | August 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Combination Product
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
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Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets |
Active Comparator: Paracetamol tablets
Paracetamol (500 mg) tablets
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Drug: Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets |
- Physician Global Evaluation of Effectiveness on Nasal Symptoms [ Time Frame: 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
- Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms [ Time Frame: 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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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.
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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/exclusion criteria may apply

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448057
Brazil | |
Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia | |
Belo Horizonte/MG, Brazil, 30150-221 | |
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, Brazil, 60170-320 | |
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, Brazil, 17210-070 | |
Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino | |
Sao Paulo, Brazil | |
: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos | |
São Paulo, Brazil, 13271-130 |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT01448057 |
Other Study ID Numbers: |
381-A-301 |
First Posted: | October 7, 2011 Key Record Dates |
Results First Posted: | January 13, 2017 |
Last Update Posted: | March 3, 2017 |
Last Verified: | January 2017 |
Paracetamol dimethindene maleate phenylephrine hydrochloride cold and flu symptoms |
Respiratory Tract Infections Rhinorrhea Sneezing Infections Respiratory Tract Diseases Signs and Symptoms, Respiratory Acetaminophen Dimethindene Phenylephrine Oxymetazoline Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Antipyretics Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Mydriatics Autonomic Agents Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Protective Agents |