Upper Respiratory Tract InfectionPhase 3NCT01448057

Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

A Phase 3 study testing Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets and Paracetamol (500 mg) tablets in people with Upper Respiratory Tract Infection and Nasal Congestion, run by Novartis at 6 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea
What is being tested?: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets and Paracetamol (500 mg) tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 6 sitesBrazil
Study dates: Jul 2013to Aug 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Brazil6 sites

Santa Casa De Misericordia De Belo Horizonte - Avenida Francisco Sales 1111, Santa Efigenia
Belo Horizonte/MG, 30150-221
Sociedade Campineira De Educacao E Instrucao - Rodovia Dom Pedro I, KM 136 Parque das Universidades
Campinas/SP
Instituto de Ensino e Pesquisa Clínica do Ceará, Rua Coronel Jucá, 1952 - Dionísio Torres -
Fortaleza/CE, 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, 17210-070
: Lal Clinica Centro de Pesquisa e Desenvolvimento Ltda, Rua General Osório, 503, Vila Martina / Valinhos
São Paulo, 13271-130
Associacao Fundo De Incentivo A Pesquisa - AFIP - Rua Marselhesa 500 - Vila Clementino
São Paulo

Other trials in Brazil

About this study

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

Conditions: Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea, Sneezing
Being tested: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets, Paracetamol (500 mg) tablets
Keywords: Paracetamol, dimethindene maleate, phenylephrine hydrochloride, cold and flu symptoms
Medical subject headings: Respiratory Tract Infections, Nasal Obstruction, Rhinorrhea, Sneezing, Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tabletsDrug
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol (500 mg) tabletsDrug
Paracetamol (500 mg) tablets

Study groups in NCT01448057
Study group	Role	What they receive
Combination Product	Experimental	Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets Receives: Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol tablets	Active comparator	Paracetamol (500 mg) tablets Receives: Drug: Paracetamol (500 mg) tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Day 2

Secondary outcomes (1)

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
Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Aug 2015

First posted7 Oct 2011 (estimated)
Study startJul 2013
Primary completionAug 2015
Study completionAug 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01448057
Sponsor's protocol ID: 381-A-301
Status last verified: Jan 2017
First submitted: 5 Oct 2011
Last updated: 3 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
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RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
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Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
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All Upper Respiratory Tract Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01448057
Acronym / sponsor ID: 381-A-301
Conditions: Upper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea, Sneezing
Keywords: Paracetamol, dimethindene maleate, phenylephrine hydrochloride, cold and flu symptoms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 7 Oct 2011 (estimated)
Results: Posted 13 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Combination Product	Experimental	Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tabletsParacetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
Paracetamol tablets	Active comparator	Drug: Paracetamol (500 mg) tabletsParacetamol (500 mg) tablets

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Key exclusion criteria (3 listed)

Other protocol-defined inclusion/exclusion criteria may apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tabletsParacetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets	Drug	Combination Product
Paracetamol (500 mg) tabletsParacetamol (500 mg) tablets	Drug	Paracetamol tablets

Primary outcome

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

1 secondary outcome

Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms
Time frame: Day 3

Results and safety

Results posted to the registry on 13 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Product	170	162
Paracetamol Tablets	171	167

Primary outcome: Physician Global Evaluation of Effectiveness on Nasal Symptoms

Time frame: Day 2. Mean (Standard Deviation). Unit: score on a scale

Measure	Arm A n = 162	Arm B n = 170
Value	1.9 (0.84)	2.1 (0.91)

Population analysed: In the combination product arm 8 subjects had missing assessment and 1 subject in the paracetamol arm

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 3 days. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A	0 of 170 (0%)	77 of 170 (45.3%)	Not reported
Arm B	0 of 171 (0%)	39 of 171 (22.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Upper Respiratory Tract Infection

RecruitingPhase 1
A Clinical Trial of V175 and V175A in Healthy Adults
Lower Respiratory Tract Infection
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
Lower Respiratory Tract Infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
Vocxi Breath Analyzer Study in Pediatric Respiratory Infection
Acute Respiratory Illness, Viral Respiratory Infection

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physician Global Evaluation of Effectiveness on Nasal Symptoms (time frame: Day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01448057.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.