The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
494
low dose Ambroxol Spray
medium dose Ambroxol Spray
high dose Ambroxol Spray
18.504.27015 Boehringer Ingelheim Investigational Site
Bloemfontein, South Africa
18.504.27005 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
The primary endpoint is the time-weighted average of the pain intensity difference (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h).
Time frame: 2 hours
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 3 hours after the first spray application and the corresponding SPIDnorm0-3h
Time frame: 3 hours
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 4, 6, 12 and 24 hours after the first spray application and the corresponding SPIDnorm0-24h
Time frame: 4, 6, 12 and 24 hours
Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.
Time frame: 3 and 24 hours
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Placebo Spray
18.504.27011 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27013 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27014 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
18.504.27008 Boehringer Ingelheim Investigational Site
Durban, South Africa
18.504.27010 Boehringer Ingelheim Investigational Site
Durban, South Africa
18.504.27001 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
18.504.27004 Boehringer Ingelheim Investigational Site
Klipspruit West, South Africa
18.504.27003 Boehringer Ingelheim Investigational Site
Krugersdorp, South Africa
...and 5 more locations