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.

Study Overview

• Status: Completed
• Conditions: Common Cold; Pharyngitis
• Intervention / Treatment: Drug: Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + Pseudoephedrine; Drug: Acetylsalicylic Acid (Aspirin, BAYE4465); Drug: Pseudoephedrine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1016
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Alassio, Italy, 17021
  • Albenga, Italy, 17031
  • Arenzano, Italy, 16011
  • Civitella Paganico, Italy, 58048
  • Follonica, Italy, 58022
  • Genova, Italy, 16010
  • Genova, Italy, 16125
  • Genova, Italy, 16128
  • Genova, Italy, 16129
  • Genova, Italy, 16131
  • Genova, Italy, 16137
  • Genova, Italy, 16143
  • Genova, Italy, 16149
  • Genova, Italy, 16161
  • Genova, Italy, 16162
  • Grosseto, Italy, 58100
  • Grossetto, Italy, 58100
  • Isola del Cantone, Italy, 16017
  • Loano, Italy, 17025
  • Masone, Italy, 16010
  • Orbetello, Italy, 58100
  • Pegli, Italy, 16100
  • Quiliano, Italy, 17047
  • Rivarolo, Italy, 16150
  • Ronco Scrivia, Italy, 16019
  • Sampierdarena, Italy, 16151
  • Scansano, Italy, 58054
  • Serra Ricco, Italy, 16010
  • Varazze, Italy, 17019
• Poland
  • Ciechocin, Poland, 87-408
  • Debowa Gora, Poland, 96-116
  • Kattowitz, Poland, 40-226
  • Kattowitz, Poland, 40-520
  • Kattowitz, Poland, 40-752
  • Krakau, Poland, 31-215
  • Lodzi, Poland, 93-105
  • Piaseczno, Poland, 05-500
  • Skierniewice, Poland, 96-100
  • Szczecin, Poland, 71-140
  • Szczecin, Poland, 71-502
  • Thorn, Poland, 87-100
  • Warszawa, Poland, 02-097
  • Warszawa, Poland, 02-793
  • Warszawa, Poland, 01-493
  • Warszawa, Poland, 01-961
  • Warszawa, Poland, 02-091
  • Warszawa, Poland, 03-185
  • Zabrze, Poland, 41-800
• Slovakia
  • Bratislava, Slovakia, 85101
  • Bratislava, Slovakia, 81107
  • Bratislava, Slovakia, 84101
  • Bratislava, Slovakia, 84104
  • Bratislava, Slovakia, 84107
  • Bratislava, Slovakia, 85102
  • Bratislava, Slovakia, 85105
  • Pezinok, Slovakia, 90201
  • Stupava, Slovakia, 90031
• United States
  • New York
    • New York, New York, United States, 11021
    • New York, New York, United States, 11743

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2005
• Primary Completion (Actual): May 14, 2007
• Study Completion (Actual): May 14, 2007

Study Registration Dates

• First Submitted: December 9, 2009
• First Submitted That Met QC Criteria: February 3, 2010
• First Posted (Estimate): February 4, 2010

Study Record Updates

• Last Update Posted (Actual): September 1, 2017
• Last Update Submitted That Met QC Criteria: August 31, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Sore Throat; Nasal Congestion; Upper Respiratory Tract Infections
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Picornaviridae Infections; Common Cold; Pharyngitis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Aspirin; Ephedrine; Pseudoephedrine
• Other Study ID Numbers: 11764; 2005-001720-36 (EudraCT Number)