Trial Condition(s):
Common Cold, Pharyngitis
Placebo and active controlled Study to assess efficacy and tolerability of Aspirin plus Pseudoephedrine
Bayer Identifier:
11764
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Alassio, Italy, 17021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Civitella Paganico, Italy, 58048 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Follonica, Italy, 58022 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16128 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16129 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16137 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16143 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16162 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grosseto, Italy, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Grossetto, Italy, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Isola del Cantone, Italy, 16017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Loano, Italy, 17025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Masone, Italy, 16010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ronco Scrivia, Italy, 16019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sampierdarena, Italy, 16151 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Scansano, Italy, 58054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Serra Ricco, Italy, 16010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ciechocin, Poland, 87-408 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Debowa Gora, Poland, 96-116 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kattowitz, Poland, 40-226 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kattowitz, Poland, 40-520 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Albenga, Italy, 17031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Arenzano, Italy, 16011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16125 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Genova, Italy, 16161 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Orbetello, Italy, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pegli, Italy, 16100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Quiliano, Italy, 17047 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rivarolo, Italy, 16150 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Varazze, Italy, 17019 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Krakau, Poland, 31-215 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Piaseczno, Poland, 05-500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Skierniewice, Poland, 96-100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 71-140 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Thorn, Poland, 87-100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 01-493 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 03-185 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 84101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 84104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 84107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 85101 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kattowitz, Poland, 40-752 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lodzi, Poland, 93-105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Szczecin, Poland, 71-502 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 01-961 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-091 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Warszawa, Poland, 02-793 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Zabrze, Poland, 41-800 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 81107 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 85102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 11021 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New York, United States, 11743 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 85105 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pezinok, Slovakia, 90201 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Stupava, Slovakia, 90031 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosingTimeframe: 2 hours
- The primary efficacy parameter for sore throat was SPID2 hoursTimeframe: 2 hours
Secondary Outcome
- The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first doseTimeframe: 15, 30, 60, 90, 120, 240, and 360 minutes
- The Nasal Congestion ScoreTimeframe: 15, 30, 60, 90, 120, 240, and 360 minutes
- The Nasal Congestion Relief ScoreTimeframe: 15, 30, 60, 90, 120, 240, and 360 minutes
- Sore throat pain reliefTimeframe: 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 doseTimeframe: 120 minutes
- The results of an overall assessment of treatment by the subjects at 120 minutes post doseTimeframe: 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)Timeframe: 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)Timeframe: 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)Timeframe: Day 2 and Day 3
- Total amount of drug intakeTimeframe: Day 3
Additional Information
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