check_circleStudy Completed

Common cold, Pharyngitis, Tonsillitis

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

Both

Age

18 - None N/A

Trial summary

Enrollment Goal
1088
Trial Dates
November 2004 - May 2005
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Bayer Advanced Aspirin (Acetylsalicylic acid, BAY1019036)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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Withdrawn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 SPID
    date_rangeTime Frame:
    120 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Pain intensity difference to baseline (PID12 min)
    date_rangeTime Frame:
    12 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Pain intensity difference to baseline (PID120 min)
    date_rangeTime Frame:
    120 minutes
    enhanced_encryption
    Safety Issue:
    No

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 dose
    enhanced_encryption
    Safety Issue:
    No
  • 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 dose
    enhanced_encryption
    Safety Issue:
    No
  • Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)
    date_rangeTime Frame:
    60, 120, 180, and 240 minutes post dose
    enhanced_encryption
    Safety Issue:
    No
  • Overall assessment of treatment
    date_rangeTime Frame:
    240 minutes
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of safety and tolerability
    date_rangeTime Frame:
    240 minutes
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

A 4-arm, multicenter, randomized, double-blind, placebo- and active-controlled, single dose, parallel group study comparing efficacy and safety of a fixed combination of 500 mg Acetylsalicylic Acid + 4 mg Lidocaine with 500 mg Acetylsalicylic Acid and 4 mg Lidocaine monotherapy as well as Placebo in adult patients with sore throat associated with a common cold.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
4