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

NCT ID: NCT02084511

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-10-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 1026706 low dose

BI 1026706 low dose

Group Type: EXPERIMENTAL

Placebo to BI 1026706 solution

Intervention Type: DRUG

Placebo to BI 1026706 solution

BI 1026706

Intervention Type: DRUG

BI 1026706

Placebo to BI 1026706 tablet

Intervention Type: DRUG

Placebo to BI 1026706 tablet

BI 1026706 high dose

BI 1026706 high dose

Group Type: EXPERIMENTAL

BI 1026706

Intervention Type: DRUG

BI 1026706

Placebo to BI 1026706 tablet

Intervention Type: DRUG

Placebo to BI 1026706 tablet

Placebo reference

Placebo reference

Group Type: EXPERIMENTAL

Placebo to BI 1026706 solution

Intervention Type: DRUG

Placebo to BI 1026706 solution

Placebo to BI 1026706 tablet

Intervention Type: DRUG

Placebo to BI 1026706 tablet

Celecoxib reference

Celecoxib capsule

Group Type: EXPERIMENTAL

Placebo to BI 1026706 solution

Intervention Type: DRUG

Placebo to BI 1026706 solution

Celecoxib

Intervention Type: DRUG

Celecoxib capsule

Interventions

Placebo to BI 1026706 solution

Placebo to BI 1026706 solution

Intervention Type: DRUG

BI 1026706

BI 1026706

Intervention Type: DRUG

Placebo to BI 1026706 tablet

Placebo to BI 1026706 tablet

Intervention Type: DRUG

Celecoxib

Celecoxib capsule

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1320.13.39001 Boehringer Ingelheim Investigational Site

Verona, , Italy

Countries

Italy

Other Identifiers

2013-003580-62

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1320.13

Identifier Type: -

Identifier Source: org_study_id