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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Common Cold, Pharyngitis

Intervention / Treatment
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* Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine
* Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)
* Drug: Pseudoephedrine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine<br>* 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.<br>|
| Active Comparator: Arm 2<br> | Drug: Acetylsalicylic Acid (Aspirin, BAYE4465)<br>* 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.<br>|
| Active Comparator: Arm 3<br> | Drug: Pseudoephedrine<br>* 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.<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing |  | 2 hours | 
| The primary efficacy parameter for sore throat was SPID2 hours |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose |  | 15, 30, 60, 90, 120, 240, and 360 minutes | 
| The Nasal Congestion Score |  | 15, 30, 60, 90, 120, 240, and 360 minutes | 
| The Nasal Congestion Relief Score |  | 15, 30, 60, 90, 120, 240, and 360 minutes | 
| Sore throat pain relief |  | 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 |  | 120 minutes | 
| The results of an overall assessment of treatment by the subjects at 120 minutes post dose |  | 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) |  | 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) |  | 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) |  | Day 2 and Day 3 | 
| Total amount of drug intake |  | Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sore Throat, Upper Respiratory Tract Infections, Nasal Congestion