check_circleStudy Completed
Common Cold, Pharyngitis
Bayer Identifier:
11764
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Placebo and active controlled Study to assess efficacy and tolerability of Aspirin plus Pseudoephedrine
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.
Key Participants Requirements
Sex
BothAge
18 - 65 YearsTrial summary
Enrollment Goal
1016Trial Dates
December 2005 - May 2007Phase
Phase 3Could I Receive a placebo
YesProducts
Aspirin (Acetylsalicylic Acid, BAYE4465)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Alassio, 17021, Italy | |
Completed | Civitella Paganico, 58048, Italy | |
Completed | Follonica, 58022, Italy | |
Completed | Genova, 16010, Italy | |
Completed | Genova, 16128, Italy | |
Completed | Genova, 16129, Italy | |
Completed | Genova, 16131, Italy | |
Completed | Genova, 16137, Italy | |
Completed | Genova, 16143, Italy | |
Completed | Genova, 16162, Italy | |
Completed | Grosseto, 58100, Italy | |
Completed | Grossetto, 58100, Italy | |
Completed | Isola del Cantone, 16017, Italy | |
Completed | Loano, 17025, Italy | |
Completed | Masone, 16010, Italy | |
Completed | Ronco Scrivia, 16019, Italy | |
Completed | Sampierdarena, 16151, Italy | |
Completed | Scansano, 58054, Italy | |
Completed | Serra Ricco, 16010, Italy | |
Completed | Ciechocin, 87-408, Poland | |
Completed | Debowa Gora, 96-116, Poland | |
Completed | Kattowitz, 40-226, Poland | |
Completed | Kattowitz, 40-520, Poland | |
Completed | Alassio, 17021, Italy | |
Completed | Albenga, 17031, Italy | |
Completed | Arenzano, 16011, Italy | |
Completed | Follonica, 58022, Italy | |
Completed | Genova, 16125, Italy | |
Completed | Genova, 16149, Italy | |
Completed | Genova, 16161, Italy | |
Completed | Orbetello, 58100, Italy | |
Completed | Pegli, 16100, Italy | |
Completed | Quiliano, 17047, Italy | |
Completed | Rivarolo, 16150, Italy | |
Completed | Varazze, 17019, Italy | |
Completed | Krakau, 31-215, Poland | |
Completed | Piaseczno, 05-500, Poland | |
Completed | Skierniewice, 96-100, Poland | |
Completed | Szczecin, 71-140, Poland | |
Completed | Thorn, 87-100, Poland | |
Completed | Warszawa, 01-493, Poland | |
Completed | Warszawa, 03-185, Poland | |
Completed | Bratislava, 84101, Slovakia | |
Completed | Bratislava, 84104, Slovakia | |
Completed | Bratislava, 84107, Slovakia | |
Completed | Bratislava, 85101, Slovakia | |
Completed | Kattowitz, 40-752, Poland | |
Completed | Lodzi, 93-105, Poland | |
Completed | Szczecin, 71-502, Poland | |
Completed | Warszawa, 01-961, Poland | |
Completed | Warszawa, 02-091, Poland | |
Completed | Warszawa, 02-097, Poland | |
Completed | Warszawa, 02-793, Poland | |
Completed | Zabrze, 41-800, Poland | |
Completed | Bratislava, 81107, Slovakia | |
Completed | Bratislava, 84107, Slovakia | |
Completed | Bratislava, 85102, Slovakia | |
Completed | New York, 11021, United States | |
Completed | New York, 11743, United States | |
Completed | Bratislava, 85105, Slovakia | |
Completed | Pezinok, 90201, Slovakia | |
Completed | Stupava, 90031, Slovakia | |
Completed | Skierniewice, 96-100, Poland | |
Completed | Skierniewice, 96-100, Poland | |
Completed | Debowa Gora, 96-116, Poland | |
Completed | Bratislava, 85101, Slovakia | |
Completed | Bratislava, 84107, Slovakia | |
Completed | Bratislava, 85101, Slovakia | |
Completed | Bratislava, 85102, Slovakia | |
Completed | Bratislava, 84101, Slovakia | |
Completed | Bratislava, 84107, Slovakia | |
Completed | Bratislava, 84107, Slovakia | |
Completed | Bratislava, 84104, Slovakia | |
Completed | Bratislava, 81107, Slovakia | |
Completed | Pezinok, 90201, Slovakia | |
Completed | Bratislava, 85105, Slovakia | |
Completed | New York, 11021, United States |
Primary Outcome
- The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosingdate_rangeTime Frame:2 hoursenhanced_encryptionnoSafety Issue:
- The primary efficacy parameter for sore throat was SPID2 hoursdate_rangeTime Frame:2 hoursenhanced_encryptionnoSafety Issue:
Secondary Outcome
- The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dosedate_rangeTime Frame:15, 30, 60, 90, 120, 240, and 360 minutesenhanced_encryptionnoSafety Issue:
- The Nasal Congestion Scoredate_rangeTime Frame:15, 30, 60, 90, 120, 240, and 360 minutesenhanced_encryptionnoSafety Issue:
- The Nasal Congestion Relief Scoredate_rangeTime Frame:15, 30, 60, 90, 120, 240, and 360 minutesenhanced_encryptionnoSafety Issue:
- Sore throat pain reliefdate_rangeTime Frame:15, 30, 60, 90, 120, 240, and 360 minutesenhanced_encryptionnoSafety Issue:
- The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dosedate_rangeTime Frame:120 minutesenhanced_encryptionnoSafety Issue:
- The results of an overall assessment of treatment by the subjects at 120 minutes post dosedate_rangeTime Frame:120 minutesenhanced_encryptionnoSafety Issue:
- 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)date_rangeTime Frame:Day 3enhanced_encryptionnoSafety Issue:
- 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)date_rangeTime Frame:Day 3enhanced_encryptionnoSafety Issue:
- 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)date_rangeTime Frame:Day 2 and Day 3enhanced_encryptionnoSafety Issue:
- Total amount of drug intakedate_rangeTime Frame:Day 3enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
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