Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
- Conditions
- Pain, Postoperative
- Interventions
- Drug: Placebo to BI 1026706 solutionDrug: Placebo to BI 1026706 tablet
- Registration Number
- NCT02084511
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BI 1026706 high dose BI 1026706 BI 1026706 high dose BI 1026706 low dose Placebo to BI 1026706 tablet BI 1026706 low dose BI 1026706 low dose Placebo to BI 1026706 solution BI 1026706 low dose BI 1026706 low dose BI 1026706 BI 1026706 low dose Placebo reference Placebo to BI 1026706 solution Placebo reference BI 1026706 high dose Placebo to BI 1026706 tablet BI 1026706 high dose Placebo reference Placebo to BI 1026706 tablet Placebo reference Celecoxib reference Placebo to BI 1026706 solution Celecoxib capsule Celecoxib reference Celecoxib Celecoxib capsule
- Primary Outcome Measures
Name Time Method SPID0-8h up to 8 hours post drug administration 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.
- Secondary Outcome Measures
Name Time Method Time to Meaningful Pain Relief up to 10 hours post drug administration 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 to First Dose of Rescue Medication up to 10 hours post drug administration 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.SPID0-2h up to 2 hours post drug administration 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.
Percentage of Patients With Drug-related Adverse Events From first drug administration until 3 days after last drug administration, upto 4 days Percentage of patients with drug-related adverse events
TOTPAR0-8h up to 8 hours post drug administration 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.
Trial Locations
- Locations (1)
1320.13.39001 Boehringer Ingelheim Investigational Site
🇮🇹Verona, Italy