Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003580-62 | EudraCT Number | EudraCT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1026706 low dose | Experimental | BI 1026706 low dose |
|
| BI 1026706 high dose | Experimental | BI 1026706 high dose |
|
| Placebo reference | Experimental | Placebo reference |
|
| Celecoxib reference | Experimental | Celecoxib capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo to BI 1026706 solution | Drug | Placebo to BI 1026706 solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 8 hours post drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 8 hours post drug administration |
| SPID0-2h |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1320.13.39001 Boehringer Ingelheim Investigational Site | Verona | Italy |
This was a randomised, placebo and active comparator-controlled, partially double-blinded, single-dose, parallel-group, single-centre trial in male patients in double dummy design investigating 4 different treatments.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | BI 50 mg PfOS | This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet. |
| FG001 | BI 200 mg PfOS | This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet. |
| FG002 | Placebo | This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet. |
| FG003 | Celecoxib 200 mg | This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Treated set: The treated set (TS) included all randomised patients who received study medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | BI 50 mg PfOS | This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The pharmacodynamic set (PD set) included all subjects of the Treated set (TS) who provided at least 1 primary or secondary PD endpoint value that was not flagged for exclusion. | Posted | Least Squares Mean | 95% Confidence Interval | units on scale | up to 8 hours post drug administration |
|
From first drug administration until 3 days after last drug administration, upto 4 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BI 50 mg PfOS | This trial has double dummy design, thus subjects were orally administered single dose of 50 mg of Boehringer Ingelheim (BI) 1026706 powder for oral solution (PfOS) with 200 mL of water plus matching placebo to BI 1026706 PfOS (to have 80 mL volume in total) and a placebo film-coated tablet. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068579 | Celecoxib |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BI 1026706 | Drug | BI 1026706 |
|
| Placebo to BI 1026706 tablet | Drug | Placebo to BI 1026706 tablet |
|
| Celecoxib | Drug | Celecoxib capsule |
|
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. |
| 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. | 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. | up to 10 hours post drug administration |
| Percentage of Patients With Drug-related Adverse Events | Percentage of patients with drug-related adverse events | From first drug administration until 3 days after last drug administration, upto 4 days |
| BI 200 mg PfOS |
This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet. |
| BG002 | Placebo | This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet. |
| BG003 | Celecoxib 200 mg | This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS. |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | BI 200 mg PfOS | This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet. |
| OG002 | Placebo | This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet. |
| OG003 | Celecoxib 200 mg | This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS. |
|
|
|
| Secondary | 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. | PD Set | Posted | Least Squares Mean | 95% Confidence Interval | units on scale | up to 8 hours post drug administration |
|
|
|
|
| Secondary | 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. | PD set | Posted | Least Squares Mean | 95% Confidence Interval | units on scale | up to 2 hours post drug administration |
|
|
|
|
| Secondary | 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. | PD set | Posted | Median | 95% Confidence Interval | hours | up to 10 hours post drug administration |
|
|
|
|
| Secondary | 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. | PD set | Posted | Median | 95% Confidence Interval | hours | up to 10 hours post drug administration |
|
|
|
|
| Secondary | Percentage of Patients With Drug-related Adverse Events | Percentage of patients with drug-related adverse events | Treated Set | Posted | Number | Percentage of participants | From first drug administration until 3 days after last drug administration, upto 4 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | BI 200 mg PfOS | This trial has double dummy design, thus subjects were orally administered single dose of 200 mg of BI 1026706 powder for oral solution (PfOS) with 200 mL of water and a placebo film-coated tablet. | 0 | 20 | 0 | 20 |
| EG002 | Placebo | This trial has double dummy design, thus subjects were orally administered single dose of matching placebo to BI 1026706 powder for oral solution with 200 mL of water and placebo film coated tablet. | 0 | 20 | 0 | 20 |
| EG003 | Celecoxib 200 mg | This trial has double dummy design, thus subjects were orally administered single dose of Celecoxib hard capsule of 200 mg with 200 mL of water plus matching placebo to BI 1026706 PfOS. | 0 | 20 | 0 | 20 |
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term. |
| Median Difference (Final Values) |
| 0.98 |
| 2-Sided |
| 95 |
| -3.0 |
| 5.0 |
Mean difference (final values) is actually the Least square mean |
| Superiority or Other |
| ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term. | Mean Difference (Final Values) | -6.27 | 2-Sided | 95 | -10.3 | -2.2 | Mean difference (final values) is actually the Least square mean | Superiority or Other |
| ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term. | Mean Difference (Final Values) | -6.98 | 2-Sided | 95 | -11.0 | -2.9 | Mean difference (final values) is actually the Least square mean | Superiority or Other |
ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term. |
| Mean Difference (Final Values) |
| 20.58 |
| 2-Sided |
| 95 |
| -1.3 |
| 42.5 |
Mean difference (final values) is actually the Least square mean |
| Superiority or Other |
| ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term. | Mean Difference (Final Values) | -13.29 | 2-Sided | 95 | -35.2 | 8.6 | Mean difference (final values) is actually the Least square mean | Superiority or Other |
| ANCOVA model was used with 'treatment' as fixed effect, 'patient baseline pain intensity (BPI)' as continuous covariate and the residual error term. | Mean Difference (Final Values) | 1.37 | 2-Sided | 95 | -20.6 | 23.3 | Mean difference (final values) is actually the Least square mean | Superiority or Other |
| Log Rank |
| 0.1851 |
| Superiority or Other |
| Log rank test used to evaluate the difference between each active treatment and placebo. | Log Rank | 0.0167 | Superiority or Other |
| Log Rank |
| 0.3093 |
| Superiority or Other |
| Log rank test used to evaluate the difference between each active treatment and placebo. | Log Rank | 0.0074 | Superiority or Other |