Desloratadine,Phenylephrine Hcl,Ibuprofen Compared to Placebo in Treatment of Symptoms Associated With Common Cold/Flu

NCT02904304 | Suspended Phase 3

• 1 other identifier: ACH-DNT-03(02/16)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

National clinical trial, phase III, multicenter, randomized, prospective, double-blind, parallel, placebo-controlled, which one hundred and fifty (150) subjects of both sexes aged equal or more than 18 years will be randomly allocated to one the drug group or placebo group.

Conditions

Cold

Keywords

Flu; Treatment

Outcome Measures

Primary Outcomes (1)

• Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo

  To evaluate the association of the superiority fixed dose of desloratadine 2.5mg, 20mg phenylephrine hydrochloride and ibuprofen 400 mg compared to placebo in the treatment of symptoms related to the common cold / flu syndrome by varying the intensity total score of symptoms, three (03 ) hours after the first dose of investigational product.

  03 hours after the first dose

Secondary Outcomes (4)

• Evaluation of the symptoms related to the common cold / flu syndrome.

  02 days after initiation of treatment, compared to baseline.

• Satisfaction of the quality of sleep

  On the first day and on the second day after the start of treatment.

• The need for use of the rescue medication measured through the subject's diary.

  On the first day and on the second day after the start of treatment.

• The need for use of the rescue medication according to accounting of rescue medication returned.

  On the first day and on the second day after the start of treatment.

Study Arms (2)

Desloratadine+Phenylephrine+Ibuprofen

EXPERIMENTAL

It's a tablet manufactured by Aché S.A., composed of desloratadine 2,5mg, Phenylephrine hydrochloride 20mg and Ibuprofen 400mg. Tablet will be dispensed in a cartridge containing 10 tablet to 75 participants.

Drug: Desloratadine+Phenylephrine+Ibuprofen

Placebo

PLACEBO COMPARATOR

It's a tablet manufactured by Aché S.A,. composed of placebo will be dispensed in a cartridge containing 10 tablet to 75 participants. The participants shall administer the placebo tablets to enable the double-blind study. The use of placebo comparator is important in this type of pathology because with this design will be able to evaluate the response of the pure treatment, rapid relief of symptoms, or 03 hours after the first administration of study drug.

Drug: Placebo

Interventions

Desloratadine+Phenylephrine+Ibuprofen DRUG

01 tablet, orally, every 12 hours.

Also known as: Desloratadine+Phenylephrine hydrochloride+Ibuprofen

Desloratadine+Phenylephrine+Ibuprofen

Placebo DRUG

01 tablet, orally, every 12 hours.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age older or equal to 18 and younger than 66 years;
• Subjects diagnosed with common cold / flu syndrome defined by clinical evaluation and the presence of two or more of the following symptoms: sneezing, rhinorrhea, nasal obstruction, headache, throat discomfort, sore throat, dysphonia, myalgia, cough and fever classified as moderate or intense in four intensity scale (04) items (0 = absent, 01 = light, 02 = moderate, 03 = severe);
• Beginning of the symptoms of common cold / flu-like syndrome in a minimum period of 24 hours and a maximum of 72 hours prior to V0;
• Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF);

You may not qualify if:

• Any laboratorial finding (clinical evaluation / physical evaluation / vital signs / ECG changes) that the Investigator consider a risk to subject of the study;
• Hypersensitivity to the drug components used during the study;
• Women in pregnancy or nursing period;
• Women in reproductive age who do not agree to use contraception acceptable \[oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation\]; other than surgically sterile (bilateral oophorectomy or hysterectomy), postmenopausal for at least one (01) years or sexual abstinence;
• Subjects that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;
• Alcohol abuse that, according to the investigator, may interfere with the pharmacological adherence to the clinical protocol;
• Any medical conditions which may interfere with efficacy and / or safety of the treatment with the investigational product, such as but not limited to disorders described below:
• Untreated or uncontrolled Hyperthyroidism
• Uncontrolled epilepsy
• diagnosis of glaucoma
• Moderate or severe persistent asthma (untreated or uncontrolled)
• NSAID-induced asthma diagnosed
• Systemic hypertension (SH) stage III uncontrolled
• Moderate and severe congestive heart failure
• Acute myocardial infarction

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

Allergisa Pesquisa Dermato Cosmética Ltda.

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Common Cold; Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Mauro Crippa Jr.

  Allergisa Pesquisa Dermato-Cosmética Ltda

  PRINCIPAL INVESTIGATOR

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: September 16, 2016
• Study Start: December 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

BR (1)