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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 is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01938144
First received: September 4, 2013
Last updated: September 17, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    One Hour Assessment of Relief question following the first dose


Estimated Enrollment: 1200
Study Start Date: April 2015
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (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 12 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 12 doses.
Active Comparator: Treatment C
Acetaminophen 500 mg
Drug: Paracetamol
Acetaminophen 500 mg, 4x/day, up to 12 doses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 1 of the following 4 symptoms: runny nose, plugged nose, sneezing, 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 other type of cold remedies within the last 7 days prior to the screening (Appendix 2), as well as those subjects who are taking antibiotics of any kind.

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938144

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

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

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01938144     History of Changes
Other Study ID Numbers: B3971002, U1111-1147-8736
Study First Received: September 4, 2013
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration

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
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases
Ibuprofen
Phenylephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014