Efficacy and Safety Assessment of an Anti-Cold Preparation in the Symptomatic Treatment of Common Cold and Flu-Like Syndrome

NCT00940836 | Unknown Phase 3

• 1 other identifier: 05492
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the efficacy and safety of an anti-cold preparation compounded by acetaminophen, chlorpheniramine and phenylephrine for the treatment of cold and flu symptoms in healthy individuals in a randomized, double-blind, placebo-controlled clinical trial.

Conditions

Common Cold; Flu-like Syndrome

Keywords

Anti-cold; Cold preparation; RCT

Outcome Measures

Primary Outcomes (1)

• Symptom improval assessed by questionnaires concerning headache, muscle ache, rhinorrhea, nasal obstruction, sneezes, cough, sore or irritated throat, hoarseness and fever, rated by patient himself in a scale from 0 to 4, being 0-absence and 4-severe.

  Questionnaires were answered at baseline and 1st followup to the investigator and during treatment at every dose, 5 times a day, from day 1 to 3/4, through patient's diary.

Secondary Outcomes (5)

• Global duration of symptoms, assessed by the investigator through direct questioning at followup visits.

  Day 3/4 and, if no relief yet, day 10/11.

• Time of return to usual activities, such as work or gym, assessed by the investigator through direct questioning at followup visits.

  Day 3/4 and, if no relief yet, day 10/11.

• Use of co intervention for symptom relief during treatment, registered by the volunteer in patient diary, with day and hour of ingestion.

  Assessed during treatment (day 1 to 3/4) by patient diary and questioned by investigator at 1st followup visit.

• Improval of fever by reduction of axillary temperature to less than 38,1°C.

  Assessed by investigator at baseline and 1st followup visit and by patient (with termometer provided by the study) along with every dose, 5 times a day, from day 1 to 3/4, registered in patient diary.

• Adverse effect appearance during and until 7 days after treatment, assessed through patient's report in the diary or followup visit, through physical evaluation at followup and by laboratory exams.

  Days 1 to 3/4 through patient diary, and followup at days 3/4 an 10/11.

Study Arms (2)

Resfenol

ACTIVE COMPARATOR

Patients in this arm will receive 15 capsules containing a combination described below. They are instructed to take one capsule at 7, 11, 15, 19 and 23h every day, starting after baseline evaluation. The duration of the treatment goes from 48 to 72 hours, depending on patient availability for the second evaluation. Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day.

Drug: Resfenol; Drug: Co interventional acetaminophen

Placebo

PLACEBO COMPARATOR

Patients in this arm will receive 15 capsules of placebo, that they are instructed to take in the same posology and in the same duration than the active comparator. Patients also receive co interventional acetaminophen pills, that they are allowed to take in case of persisting pain or fever, up to 4 times a day.

Drug: Placebo; Drug: Co interventional acetaminophen

Interventions

Resfenol DRUG

Each capsule of the active drug contains 400mg of acetaminophen, 4mg of chlorpheniramine and 4mg of phenylephrine. Patients will receive up to five capsules a day.

Also known as: Anti-cold preparation, Acetaminophen, Chlorpheniramine, Phenylephrine

Resfenol

Placebo DRUG

Patients in this group will receive placebo capsules up to five times a day, with the exact same taste and appearance as the active comparator.

Placebo

Co interventional acetaminophen DRUG

All patients received, along with the assigned intervention, 12 acetaminophen 500mg pills, that they were instructed to take only in case of persisting PAIN or FEVER, up to 4 times a day.

Also known as: Rescue medication, Acetaminophen, Paracetamol, Co intervention

Placebo; Resfenol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 to 60 years old;
• Presenting with at least 6 and at max 72 hours of common cold symptoms (headache, muscle ache, rhinorrhea, nasal obstruction, sneezing, cough, sore or irritated throat, hoarseness, fever) or flu-like syndrome (high fever, muscle or articular ache, headache), with at least two symptoms rated by the patient as moderated to severe in an 0 to 4 scale;
• Proper anticonception, in the case of women in fertile age;
• Possibility to abstain from using any other drug for the treatment of the studied condition, except in emergencies, in wich case the responsible party must be immediately notified;
• Cooperation and understanding skills;
• Agreement to informed consent form.

You may not qualify if:

• Pregnant or lactating women;
• Hypersensitivity to any of the drug's components;
• Alcohol or substance abuse;
• Use of MAO inhibitor or barbituric;
• Diagnosis of any acute disease in current activity or uncontrolled chronic disease;
• Clinical evidence of immunosuppression;
• Need for antibiotic treatment for the respiratory infection, in the opinion of the investigator;

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Common Cold

Interventions

Acetaminophen; Chlorpheniramine; Phenylephrine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols

Central Study Contacts

Paulo D Picon, MD, PhD

CONTACT

55 xx 51 33598752; paulopicon@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 16, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Last Updated: July 16, 2009

Record last verified: 2009-07

Locations

BR (1)