To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
1320.13.39001 Boehringer Ingelheim Investigational Site
Verona, Italy
SPID0-8h
Time-weighted sum of pain intensity difference (PID) from 0 to 8 hours post drug administration (SPID0-8h). SPID0-8h: possible range (-400; 800). The greater SPID0-8 the greater the reduction of pain intensity over the first 8 hours post drug administration.
Time frame: up to 8 hours post drug administration
TOTPAR0-8h
Time-weighted total pain relief (PAR) from 0 to 8 hours (TOTPAR0-8h). (TOTPAR0-8h)TOTPAR0-8h: possible range (0;32). The greater TOTPAR0-8h the more pain relief was experienced over the first 8 hours post drug administration.
Time frame: up to 8 hours post drug administration
SPID0-2h
Time-weighted sum of PID from 0 to 2 hours (SPID0-2h). SPID0-2h: possible range (-100; 200). The greater SPID0-2 the greater the reduction of pain intensity over the first 2 hours post drug administration.
Time frame: up to 2 hours post drug administration
Time to Meaningful Pain Relief
Time to meaningful pain relief was captured by a stopwatch started by the trial staff immediately after administration of study medication and stopped by the subject as soon as a meaningful pain relief was felt by the subject. If a subject did not have any meaningful pain relief up to 10 h, the time was censored at 10 h. Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to meaningful pain relief' were presented descriptively.
Time frame: up to 10 hours post drug administration
Time to First Dose of Rescue Medication
The time to first dose of rescue medication was defined by the difference in time of the study drug intake and the time of first rescue medication use within the first 10 h after study drug administration. Kaplan-Meier estimates over time for each treatment and time to event endpoint 'Time to first dose of rescue medication' were presented descriptively. Subjects without intake of rescue medication within the first 10 hours after study drug administration were censored at 10 hours.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Celecoxib capsule
Time frame: up to 10 hours post drug administration
Percentage of Patients With Drug-related Adverse Events
Percentage of patients with drug-related adverse events
Time frame: From first drug administration until 3 days after last drug administration, upto 4 days