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

Phase 3

Completed

• Conditions: Pharyngitis; Common Cold
• Interventions: Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine; Drug: Placebo; Drug: Pseudoephedrine

• Registration Number: NCT01062360
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-23
• Primary Completion: 2007-05-14
• Study Completion: 2007-05-14
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2010-02-03
• Study First Posted: 2010-02-04
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-31
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1016

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	Acetylsalicylic Acid (Aspirin, BAYE4465)	-
Arm 1	Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine	-
Arm 4	Placebo	-
Arm 3	Pseudoephedrine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Total amount of drug intake	Day 3
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