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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 1
Locations
Italy
Study Type
Interventional
Intervention
Placebo to BI 1026706 solution
BI 1026706
Placebo to BI 1026706 tablet
Celecoxib
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

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)

Sites / Locations

  • 1320.13.39001 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

BI 1026706 low dose

BI 1026706 high dose

Placebo reference

Celecoxib reference

Arm Description

BI 1026706 low dose

BI 1026706 high dose

Placebo reference

Celecoxib capsule

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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 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 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.
Percentage of Patients With Drug-related Adverse Events
Percentage of patients with drug-related adverse events

Full Information

First Posted
March 10, 2014
Last Updated
April 10, 2019
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT02084511
Brief Title
Effectiveness and Safety of Different Doses of BI 1026706 in Patients With Postoperative Dental Pain
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 1026706 low dose
Arm Type
Experimental
Arm Description
BI 1026706 low dose
Arm Title
BI 1026706 high dose
Arm Type
Experimental
Arm Description
BI 1026706 high dose
Arm Title
Placebo reference
Arm Type
Experimental
Arm Description
Placebo reference
Arm Title
Celecoxib reference
Arm Type
Experimental
Arm Description
Celecoxib capsule
Intervention Type
Drug
Intervention Name(s)
Placebo to BI 1026706 solution
Intervention Description
Placebo to BI 1026706 solution
Intervention Type
Drug
Intervention Name(s)
BI 1026706
Intervention Description
BI 1026706
Intervention Type
Drug
Intervention Name(s)
Placebo to BI 1026706 tablet
Intervention Description
Placebo to BI 1026706 tablet
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
Celecoxib capsule
Primary Outcome Measure Information:
Title
SPID0-8h
Description
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
Secondary Outcome Measure Information:
Title
TOTPAR0-8h
Description
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
Title
SPID0-2h
Description
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
Title
Time to Meaningful Pain Relief
Description
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
Title
Time to First Dose of Rescue Medication
Description
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.
Time Frame
up to 10 hours post drug administration
Title
Percentage of Patients With Drug-related Adverse Events
Description
Percentage of patients with drug-related adverse events
Time Frame
From first drug administration until 3 days after last drug administration, upto 4 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 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 Age 18 to 55 years (incl.) Body Mass Index 18.5 to 29.9 kg/m2 (incl.) 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; Surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). Intravenous sedations and general anaesthetics are not permitted. Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form Examined by the attending oral surgeon or physician and medically cleared to participate in the study Scheduled to undergo a qualifying surgical procedure Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation Exclusion criteria: Any finding in the medical examination (including Blod Pressure, Pulse Rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator Repeated measurement of systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg Any laboratory value outside the reference range that the investigator considers to be of clinical relevance Any evidence of a concomitant disease judged clinically relevant by the investigator Acute local infection at the time of surgery that could confound the post-surgical evaluation Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1320.13.39001 Boehringer Ingelheim Investigational Site
City
Verona
Country
Italy

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

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

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