Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
This study is not yet open for participant recruitment.
Verified March 2013 by Novartis
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01448057
First received: October 5, 2011
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Acetaminophen
Oxymetazoline
Oxymetazoline hydrochloride
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Physician Global evaluation of effectiveness on Nasal Symptoms [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]The Physician will measure the reduction of Nasal Symptoms (Nasal Congestion, Sneezing, and Rhinorrhea) on day 2
Secondary Outcome Measures:
- Sum of subject self assessment using a 100 mm Visual Analog Scale [ Time Frame: up to 3 days ] [ Designated as safety issue: No ]Subject will assess Nasal Symptoms using a 100 mm Visual Analog Scale
| Estimated Enrollment: | 244 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
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
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
|
|
Active Comparator: Arm B
Paracetamol (500 mg) tablets
|
Drug: Paracetamol (500 mg) tablets
Paracetamol (500 mg) tablets
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01448057
Contacts
| Contact: Eric Guenin | 9735037169 | eric.guenin@novartis.com |
Locations
| Brazil | |
| Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres - | Not yet recruiting |
| Fortaleza/CE, Brazil, 60170-320 | |
| Contact +55 85 3257 9646 | |
| Hospital São Lucas da PUCRS, Av. Ipiranga, 6690 - | Not yet recruiting |
| Porto Alegre/RS, Brazil, 90610-000 | |
| Contact +55 51 3384 1732 | |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre, Rua Professor Annes Dias, 295 - Centro - Pavilhão Pereira Filho - 1º Andar- | Not yet recruiting |
| Porto Alegre/RS, Brazil, 90020-090 | |
| Contact +55 51 3228 9535 | |
| : Lal Clinica Pesquisa, Rua General Osório, 507, Vila Martina / Valinhos | Not yet recruiting |
| São Paulo, Brazil, 13270000 | |
| Contact 55 19 3829 6160 | |
Sponsors and Collaborators
Novartis
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT01448057 History of Changes |
| Other Study ID Numbers: | 381-A-301 |
| Study First Received: | October 5, 2011 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Brazil: Agência Nacional de Vigilância Sanitária do Ministério da Saúde do Brasil - ANVISA/MS |
Keywords provided by Novartis:
|
Paracetamol dimethindene maleate phenylephrine hydrochloride cold and flu symptoms |
Additional relevant MeSH terms:
|
Common Cold Respiratory Tract Infections Sneezing Infection Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Picornaviridae Infections RNA Virus Infections Virus Diseases Acetaminophen Phenylephrine Oxymetazoline Dimethindene Maleic acid |
Antipyretics Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Antipruritics Dermatologic Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013