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Trial record 10 of 127 for:    "Common Cold"

Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01938144
First Posted: September 10, 2013
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg/ Phenylephrine (PE) 10 mg and IBU 200 mg/ PE 10 mg/ Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.

Condition Intervention Phase
Common Cold Drug: Advil Congestion Relief Drug: Advil Allergy and Congestion Relief Drug: Paracetamol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Three-day Clinical Evaluation Of The Efficacy And Safety Of Two Ibuprofen Combination Products For The Symptomatic Treatment Of The Common Cold And Flu: A Multicenter Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in the sum of 6 of the most common cold and flu symptoms (runny nose, plugged nose, sneezing, sore throat, scratchy throat, and head congestion), averaged over the treatment period assessed using the Wisconsin Upper Respiratory [ Time Frame: 2 Days ]
    The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.

  • Symptom Survey - 21 [ Time Frame: 2 Days ]
    The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.


Secondary Outcome Measures:
  • Change from baseline in the sum of all 10 common cold and flu symptoms, averaged over the treatment period. [ Time Frame: 2 Days ]
    The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.

  • Change from baseline in the sum of 6 of the most common symptoms at each assessment (PM day 1, AM and PM day 2) [ Time Frame: 2 Days ]
    The severity of cold/flu symptoms will be determined by the subject's response to the Wisconsin Upper Respiratory Symptom Survey, which includes questions related to the signs and symptoms of cold and flu, as well as Quality of Life Measures.

  • Symptom relief since taking the first dose [ Time Frame: 1 hours ]
    One Hour Assessment of Relief question following the first dose


Enrollment: 0
Study Start Date: April 2016
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
IBU 200 mg/ PE 10 mg
Drug: Advil Congestion Relief
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
Experimental: Treatment B
IBU 200 mg/ PE 10 mg/CHLOR 4 mg
Drug: Advil Allergy and Congestion Relief
Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
Active Comparator: Treatment C
Acetaminophen 500 mg
Drug: Paracetamol
Acetaminophen 500 mg, 4x/day, up to 8 doses.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male and female subjects who are 18 years old or older at the time of screening.

Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Subjects must present with a score of 5 of higher for at least 2 of the following 6 symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy throat, or head congestion on the WURSS-21 assessment, within 36 hours of onset of symptoms.

Exclusion Criteria:

Anyone with a history of chronic allergic rhinitis or asthma at the time of the screening visit, or with history of chronic recurrent airway disease, infections, or frequent complications of colds (otitis media, sinusitis, or bronchitis)

Subjects taking any prescription or non-prescription drug, within the last 7 days prior to the screening, with which the administration of IBU, PE, CHLOR, or APAP is contraindicated, may increase the risk associated with study participation, or may interfere with the interpretation of study results, in the judgment of the Investigator.

Subjects currently taking a monoamine oxidase (MAO) inhibitor, or has taken an MAO inhibitor within 2 months of screening.

Subjects currently taking a serotonin-selective reuptake inhibitor (SSRI), tricyclic antidepressant (TCA), barbiturate, or any other neuroleptic, or has taken an SSRI, TCA, barbiturate, or any other neuroleptic within 14 days of screening.

Subjects with a hypersensitivity to IBU, PE, or CHLOR or APAP.

  Contacts and Locations
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): NCT01938144


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01938144     History of Changes
Other Study ID Numbers: B3971002
U1111-1147-8736 ( Other Identifier: Alias Study Number )
First Submitted: September 4, 2013
First Posted: September 10, 2013
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by Pfizer:
Common cold
efficacy
symptoms
Wisconsin Upper Respiratory Symptom Survey - 21
ibuprofen
phenylephrine
pseudoephedrine

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ibuprofen
Acetaminophen
Phenylephrine
Oxymetazoline
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
Antipyretics
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists