A Phase 3 interventional study of Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine and Acetylsalicylic Acid (Aspirin, BAYE4465) in Common Cold and Pharyngitis, sponsored by Bayer. Completed at 59 sites in 4 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-09-01.
Sponsored by Bayer · Phase 3, Interventional, and Treatment
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.
180 studies on the registry are indexed under Common Cold; 22 are open to participants now.
This study's enrollment of 1,016 is above the median of 167 across 151 interventional studies indexed under Common Cold.
Browse Common Cold studies →Bayer is the lead sponsor of 1,643 studies on the registry; 56 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 130 (62%) have results posted.
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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.
Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
Drug: Pseudoephedrine
Drug: Placebo
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.
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.
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.
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.
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
The primary efficacy parameter for sore throat was SPID2 hours
Time frame: 2 hours
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
The Nasal Congestion Score
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Relief Score
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
Sore throat pain relief
Time frame: 15, 30, 60, 90, 120, 240, and 360 minutes
The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
Time frame: 120 minutes
The results of an overall assessment of treatment by the subjects at 120 minutes post dose
Time frame: 120 minutes
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
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
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
Total amount of drug intake
Time frame: Day 3
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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