Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain

Pain, Postoperative Clinical Trial

Official title:

Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain (a Single-centre, Partially Double-blinded, Randomised, placebo-and Active Comparator-controlled, Single-dose, Parallel-group Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084511
• Other study ID #: 1320.13
• Secondary ID: 2013-003580-62
• Status: Completed
• Phase: Phase 1
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: April 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion criteria:

1. Healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (Blood Pressure,Pulse Rate), 12-lead electrocardiogram, and clinical laboratory tests

2. Age 18 to 55 years (incl.)

3. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

4. Patients scheduled for removal of one mandibular third molar with partial or complete bony impaction. If medically indicated, the ipsilateral third molar in the upper jaw could also be removed;

5. Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted.

6. Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form

7. Examined by the attending oral surgeon or physician and medically cleared to participate in the study

8. Scheduled to undergo a qualifying surgical procedure

9. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

1. Any finding in the medical examination (including Blod Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator

2. Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg

3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance

4. Any evidence of a concomitant disease judged clinically relevant by the investigator

5. Acute local infection at the time of surgery that could confound the post-surgical evaluation

6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

7. Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)

Related Conditions & MeSH terms

• Pain, Postoperative
• Toothache

Intervention

Drug:
• Placebo to BI 1026706 solution
Placebo to BI 1026706 solution
• BI 1026706
BI 1026706
• Placebo to BI 1026706 tablet
Placebo to BI 1026706 tablet
• Celecoxib
Celecoxib capsule

Locations

Country	Name	City	State
Italy	1320.13.39001 Boehringer Ingelheim Investigational Site	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 8 hours post drug administration
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.	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.	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.	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.	up to 10 hours post drug administration
Secondary	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

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