Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine - Full Text View

Purpose

The purpose of this study is compare efficacy and tolerability of a fixed combination, containing 500 mg Acetylsalicylic acid and 30 mg Pseudoephedrine, in comparison to its single components in patients with sore throat and nasal congestion.

Condition	Intervention	Phase
Common Cold Pharyngitis	Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) Drug: Pseudoephedrine Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Pivotal, Placebo Controlled, Phase III Study to Compare Efficacy and Tolerability of a Fixed Combination, Containing 500 mg ASA and 30 mg Pseudoephedrine, in Comparison to Its Single Components in Patients With Sore Throat and Nasal Congestion

Resource links provided by NLM:

MedlinePlus related topics: Common Cold Sore Throat

Drug Information available for: Aspirin Pseudoephedrine

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
The primary efficacy parameter for sore throat was SPID2 hours [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose [ Time Frame: 15, 30, 60, 90, 120, 240, and 360 minutes ] [ Designated as safety issue: No ]
The Nasal Congestion Score [ Time Frame: 15, 30, 60, 90, 120, 240, and 360 minutes ] [ Designated as safety issue: No ]
The Nasal Congestion Relief Score [ Time Frame: 15, 30, 60, 90, 120, 240, and 360 minutes ] [ Designated as safety issue: No ]
Sore throat pain relief [ Time Frame: 15, 30, 60, 90, 120, 240, and 360 minutes ] [ Designated as safety issue: No ]
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
The results of an overall assessment of treatment by the subjects at 120 minutes post dose [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
The results of an overall assessment of treatment by the subjects at the end of Day 3 after the first dose, or at the end of treatment (6 hours after last dose of study drug) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
Nasal Congestion, Pain Intensity Difference and pain relief at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at the end of Day 2 and at the end of Day 3, or at the end of treatment (6 hours after the last study drug intake) [ Time Frame: Day 2 and Day 3 ] [ Designated as safety issue: No ]
Total amount of drug intake [ Time Frame: Day 3 ] [ Designated as safety issue: No ]

Enrollment:	1016
Study Start Date:	December 2005
Study Completion Date:	May 2007

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine Single oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Active Comparator: Arm 2	Drug: Acetylsalicylic Acid (Aspirin, BAYE4465) Single oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Active Comparator: Arm 3	Drug: Pseudoephedrine Single oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Placebo Comparator: Arm 4	Drug: Placebo Single oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects between 18 and 65 years of age.
Onset of cold symptoms within 96 hours (4 days) before study participation.
Current complaint of at least moderate sore throat at baseline
Current complaint of at least moderate NC at baseline
History of other symptoms associated with URTI during the last 4 days before study participation.
Other findings of URTI, confirmed on the physical examination.
Agreement to comply with the study requirements.
Written informed consent prior to enrollment in the study

Exclusion Criteria:

Pregnant or lactating females.
Uncontrolled chronic diseases.
History of hypersensitivity (allergic reaction) to ASA, any other nonsteroidal anti-inflammatory drugs (NSAIDs), or PSE.
Any disease which significantly compromises breathing or interferes with the subjects assessment of sore throat.
History of or active peptic ulcer.
Severe impaired hepatic function.
Severe impaired renal function.
Simultaneous intake of monoamine oxidase inhibitors.
Use of menthol containing tissues within 2 hours before first intake of study drug.
Intake of any menthol containing product within 4 hours before first intake of study drug.
Use of any local or systemic short acting cough and cold preparations within 6 hours before first intake of study drug.
Use of any local or systemic long acting cough and cold preparations within 12 hours before first intake of study drug.
Intake of any analgesic within 12 hours before first intake of study drug.
Intake or requirement of any prescription medication for the treatment of the current acute respiratory tract infection.
Current or previous intake of anticoagulants, corticoids, NSAIDs, methotrexate, or lithium.
Participation in another clinical trial within the last 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062360

Show 59 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Consumer Care Inc.
ClinicalTrials.gov Identifier:	NCT01062360 History of Changes
Other Study ID Numbers:	11764, 2005-001720-36
Study First Received:	December 9, 2009
Last Updated:	February 3, 2010
Health Authority:	Italy: Comitato Etico della ASL della Provincia di Varese Poland: Ministry of Health Slovakia: State Institute for Drug Control United States: Institutional Review Board

Keywords provided by Bayer:

Sore Throat
Upper Respiratory Tract Infections
Nasal Congestion

Additional relevant MeSH terms:

Aspirin
Common Cold
Pharyngitis
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Pseudoephedrine
Ephedrine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013