check_circleStudy Completed

Common Cold, Pharyngitis

Bayer Identifier:

11764

ClinicalTrials.gov Identifier:

NCT01062360

EudraCT Number:

2005-001720-36

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

Both

Age

18 - 65 Years
  • - 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
  • - 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
1016
Trial Dates
December 2005 - May 2007
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Aspirin (Acetylsalicylic Acid, BAYE4465)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 dosing
    date_rangeTime Frame:
    2 hours
    enhanced_encryption
    Safety Issue:
    no
  • The primary efficacy parameter for sore throat was SPID2 hours
    date_rangeTime Frame:
    2 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
    date_rangeTime Frame:
    15, 30, 60, 90, 120, 240, and 360 minutes
    enhanced_encryption
    Safety Issue:
    no
  • The Nasal Congestion Score
    date_rangeTime Frame:
    15, 30, 60, 90, 120, 240, and 360 minutes
    enhanced_encryption
    Safety Issue:
    no
  • The Nasal Congestion Relief Score
    date_rangeTime Frame:
    15, 30, 60, 90, 120, 240, and 360 minutes
    enhanced_encryption
    Safety Issue:
    no
  • Sore throat pain relief
    date_rangeTime Frame:
    15, 30, 60, 90, 120, 240, and 360 minutes
    enhanced_encryption
    Safety Issue:
    no
  • The symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches, and pain) at 120 minutes post dose
    date_rangeTime Frame:
    120 minutes
    enhanced_encryption
    Safety Issue:
    no
  • The results of an overall assessment of treatment by the subjects at 120 minutes post dose
    date_rangeTime Frame:
    120 minutes
    enhanced_encryption
    Safety Issue:
    no
  • 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 3
    enhanced_encryption
    Safety Issue:
    no
  • 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 3
    enhanced_encryption
    Safety Issue:
    no
  • 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 3
    enhanced_encryption
    Safety Issue:
    no
  • Total amount of drug intake
    date_rangeTime Frame:
    Day 3
    enhanced_encryption
    Safety Issue:
    no

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

Additional Information

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