check_circleStudy Completed
Common cold, Pharyngitis, Tonsillitis
Bayer Identifier:
11640
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Active and placebo controlled study to test the efficacy and safety of an Aspirin-Lidocaine lozenge in the symptomatic treatment of sore throat associated with a common cold
Trial purpose
The purpose of this study is to investigate the analgesic efficacy of a single dose of a fixed combination of 500 mg Aspirin (Acetylsalicylic Acid) and 4 mg Lidocaine in adult patients with sore throat associated with a common cold in comparison to a single treatment with 500 mg Aspirin or 4 mg Lidocaine alone as well a Placebo (treatment without any active ingredient). The combination of Aspirin and Lidocaine in a single lozenge is expected to provide relief from sore throat pain by sequential action. A very fast inset of action will be achieved by the locally acting Lidocaine and a long duration of action will be achieved by the systemically acting Aspirin.
Key Participants Requirements
Sex
BothAge
18 - None N/ATrial summary
Enrollment Goal
1088Trial Dates
November 2004 - May 2005Phase
Phase 3Could I Receive a placebo
YesProducts
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Moscow, 117393, Russian Federation | |
Completed | Moscow, 117513, Russian Federation | |
Completed | Moscow, 114765, Russian Federation | |
Completed | Moscow, 117418, Russian Federation | |
Completed | Mocow, 117574, Russian Federation | |
Completed | Moscow, 117342, Russian Federation | |
Completed | Moscow, 117342, Russian Federation | |
Completed | Moscow, 117485, Russian Federation | |
Completed | Moscow, 117485, Russian Federation | |
Completed | Moscow, 117321, Russian Federation | |
Completed | Moscow, 117588, Russian Federation | |
Completed | Moscow, 117421, Russian Federation | |
Completed | Moscow, 127299, Russian Federation | |
Completed | Moscow, 105064, Russian Federation | |
Completed | Novosibirsk, 630099, Russian Federation | |
Completed | Kiev, 02222, Ukraine | |
Completed | Kiev, 02222, Ukraine | |
Completed | Kiev, 02222, Ukraine | |
Completed | Kiev, 02222, Ukraine | |
Completed | Kiev, 02222, Ukraine | |
Completed | Kiev, 02222, Ukraine | |
Completed | Kiev, 02091, Ukraine | |
Completed | Kiev, 02091, Ukraine | |
Completed | Kiev, 02091, Ukraine | |
Completed | Lugansk, 91011, Ukraine | |
Completed | Lugansk, 91011, Ukraine | |
Completed | Lugansk, 91055, Ukraine | |
Completed | Lugansk, 91055, Ukraine | |
Completed | Lugansk, 91055, Ukraine | |
Completed | Lugansk, 91055, Ukraine | |
Completed | Lugansk, 91011, Ukraine | |
Completed | Kiev, 02232, Ukraine | |
Withdrawn | Kiev, 02232, Ukraine | |
Completed | Kiev, 02232, Ukraine | |
Completed | Kiev, 02232, Ukraine | |
Completed | Kiev, 03049, Ukraine | |
Withdrawn | Kiev, 03049, Ukraine | |
Completed | Kiev, 03049, Ukraine | |
Completed | Kiev, 03049, Ukraine | |
Completed | Kiev, 03049, Ukraine |
Primary Outcome
- Sum of pain intensity differences SPIDdate_rangeTime Frame:120 minutesenhanced_encryptionNoSafety Issue:
- Pain intensity difference to baseline (PID12 min)date_rangeTime Frame:12 minutesenhanced_encryptionNoSafety Issue:
- Pain intensity difference to baseline (PID120 min)date_rangeTime Frame:120 minutesenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Pain intensity difference to baseline (PID)date_rangeTime Frame:3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post doseenhanced_encryptionNoSafety Issue:
- Total pain relief to baseline (TOTPAR)date_rangeTime Frame:3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post doseenhanced_encryptionNoSafety Issue:
- Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)date_rangeTime Frame:60, 120, 180, and 240 minutes post doseenhanced_encryptionNoSafety Issue:
- Overall assessment of treatmentdate_rangeTime Frame:240 minutesenhanced_encryptionNoSafety Issue:
- Assessment of safety and tolerabilitydate_rangeTime Frame:240 minutesenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4Additional Information
Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.Click here and search for drug information provided by the FDAClick here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this productClick here to find results for studies related to marketed products