Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01062360
First received: December 9, 2009
Last updated: February 3, 2010
Last verified: February 2010

December 9, 2009
February 3, 2010
December 2005
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT01062360 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Common Cold
  • Pharyngitis
  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: Arm 1
    Intervention: Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
  • Active Comparator: Arm 2
    Intervention: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
  • Active Comparator: Arm 3
    Intervention: Drug: Pseudoephedrine
  • Placebo Comparator: Arm 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1016
May 2007
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Italy,   Poland,   Slovakia
 
NCT01062360
11764, 2005-001720-36
No
Therapeutic Area Head, Bayer Consumer Care Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP