Trials / Completed
CompletedNCT01361399
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
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.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,088 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain | Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge) |
| DRUG | Acetylsalicylic Acid (Aspirin, BAYE4465) | Single oral application of Aspirin (as lozenge) |
| DRUG | Lidocain | Single oral application of Lidocain (as lozenge) |
| DRUG | Placebo | Single oral application of Placebo (as lozenge) |
Timeline
- Start date
- 2004-11-30
- Primary completion
- 2005-05-28
- Completion
- 2005-05-28
- First posted
- 2011-05-26
- Last updated
- 2023-10-18
Locations
19 sites across 2 countries: Russia, Ukraine
Source: ClinicalTrials.gov record NCT01361399. Inclusion in this directory is not an endorsement.