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.
Overview
- Phase
- Phase 3
- Intervention
- Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
- Conditions
- Common Cold
- Sponsor
- Bayer
- Enrollment
- 1088
- Primary Endpoint
- Sum of pain intensity differences SPID
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Males and females of at least 18 years of age
- •Onset of common cold within the last 3 days (12 to 72 hours)
- •History of at least 4 symptoms associated with URTI in the last 24 hours out of runny nose, stuffy nose, sneezing, wet cough, dry cough, sweating, earache, ear fullness, sinus pressure/pain, head heaviness, muscle aches and pains, feverish discomfort, chills, hoarseness, sore throat, scratchy throat and headache as documented in the history of URTI
- •Current sore throat confirmed by a score ≥ 6 on a 11-category vertical ordinal scale for sore throat pain
- •Findings that confirmed the presence of tonsillopharyngitis
Exclusion Criteria
- •Pregnancy (i.e. positive pregnancy test at baseline)
- •Breastfeeding
- •History of hypersensitivity (allergic reaction) to ASA or any other NSAID
- •History of hypersensitivity (allergic reaction) to lidocaine
- •History or acute state of peptic ulceration or gastrointestinal bleeding
- •History of bleeding tendency
- •History of asthma
- •Clinical diagnosis of chickenpox or influenza
- •History or presence of severe liver or kidney disease
- •Intake of short-acting analgesics (e.g. ASA, paracetamol, ibuprofen, diclofenac) either as a single ingredient or as part of a combination cold product in the last 6 hours, or intake of long-acting analgesics (e.g. naproxen) in the last 12 hours, or intake of any other NSAID in the last 24 hours
Arms & Interventions
Arm 1
Intervention: Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain
Arm 2
Intervention: Acetylsalicylic Acid (Aspirin, BAYE4465)
Arm 3
Intervention: Lidocain
Arm 4
Intervention: Placebo
Outcomes
Primary Outcomes
Sum of pain intensity differences SPID
Time Frame: 120 minutes
Pain intensity difference to baseline (PID12 min)
Time Frame: 12 minutes
Pain intensity difference to baseline (PID120 min)
Time Frame: 120 minutes
Secondary Outcomes
- Pain intensity difference to baseline (PID)(3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose)
- Total pain relief to baseline (TOTPAR)(3, 6, 12, 18, 24, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210 and 240 minutes post dose)
- Assessment of safety and tolerability(240 minutes)
- Symptoms of common cold (headache, sinus pressure/pain, feverish discomfort, muscle aches and pain)(60, 120, 180, and 240 minutes post dose)
- Overall assessment of treatment(240 minutes)