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Trial record 60 of 58382 for:    Placebo

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

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ClinicalTrials.gov Identifier: NCT02904304
Recruitment Status : Not yet recruiting
First Posted : September 16, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.

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.

Condition or disease Intervention/treatment Phase
Cold Drug: Desloratadine+Phenylephrine+Ibuprofen Drug: Placebo Phase 3

Detailed Description:

The investigational product is a combination of desloratadine, phenylephrine hydrochloride and ibuprofen.

The desloratadine is a antihistamine and selectively block the activity of histamine receptor-1 (H1) resulting in a non sedative and prolong antiallergic effect.

The phenylephrine is a potent stimulator of the postsynaptic α receptor with minimal effect on β receptors in the heart.

The ibuprofen's mechanism is not fully known. It is a non selective inhibitor of cyclooxygenase, an enzyme that is involved in prostaglandin synthesis by the route from arachidonic acid. It is believed that the pharmacological effects are due to inhibition of cyclooxygenase-2 (COX-2), which reduces prostaglandin synthesis involved in the mediation of inflammation, pain, fever and swelling.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: National Clinical Trial,Phase III, Multicenter, Randomized, Prospective, Double-blind, Parallel, Placebo-controlled, to Evaluate the Efficacy, Safety and Superiority of Decongex Gripe in the Treatment of Symptoms Associated With Common Cold
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : November 2019


Arm Intervention/treatment
Experimental: Desloratadine+Phenylephrine+Ibuprofen

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
01 tablet, orally, every 12 hours.
Other Name: Desloratadine+Phenylephrine hydrochloride+Ibuprofen

Placebo Comparator: Placebo

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
01 tablet, orally, every 12 hours.




Primary Outcome Measures :
  1. Evaluation of the superiority of Desloratadine + Phenylephrine + Ibuprofen over placebo [ Time Frame: 03 hours after the first dose ]
    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.


Secondary Outcome Measures :
  1. Evaluation of the symptoms related to the common cold / flu syndrome. [ Time Frame: 02 days after initiation of treatment, compared to baseline. ]
    Absolute variation in total score intensity of symptoms related to the common cold / flu-like symptoms 02 days after the start of treatment compared to baseline.

  2. Satisfaction of the quality of sleep [ Time Frame: On the first day and on the second day after the start of treatment. ]
    Distribution of subjects in each treatment group as their perception to the sleep quality, assessed at baseline by answering the following statement: " Last night, with this cold, I did not sleep as well as I usually sleep "based on a scale of 0 to 4 points (0 = strongly disagree, 1 = disagree, 2 = neither agree nor disagree, 3 = agree and 4 = I totally agree).

  3. The need for use of the rescue medication measured through the subject's diary. [ Time Frame: On the first day and on the second day after the start of treatment. ]
    Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, measured through the subject's diary.

  4. The need for use of the rescue medication according to accounting of rescue medication returned. [ Time Frame: On the first day and on the second day after the start of treatment. ]
    Proportion of subject in each treatment group who used at least once the rescue medication (Tylenol®) in the first (Day 01) and on the second day (day 02) after treatment, accounting of rescue medication (Tylenol®) returned.



Information from the National Library of Medicine

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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
Criteria

Inclusion Criteria:

  • 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);

Exclusion Criteria:

  • 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
  • unstable angina
  • Uncontrolled cardiac arrhythmia
  • Liver failure with clinical consequences
  • Renal failure with clinical consequences
  • Diagnosed HIV positive
  • uncontrolled Diabetes type 1 or type 2

Information from the National Library of Medicine

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): NCT02904304


Contacts
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Contact: Elisangela Rorato +55 11 2608-6130 Elisangela.rorato@ache.com.br

Locations
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Brazil
Allergisa Pesquisa Dermato Cosmética Ltda. Not yet recruiting
Campinas, São Paulo, Brazil
Contact: Mauro Crippa Jr.    *55 19 3789-8615      
Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
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Principal Investigator: Mauro Crippa Jr. Allergisa Pesquisa Dermato Cosmética Ltda.

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Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT02904304     History of Changes
Other Study ID Numbers: ACH-DTN-03(02/16)
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Flu
Treatment

Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ibuprofen
Phenylephrine
Oxymetazoline
Desloratadine
Loratadine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists