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

NCT02084511 | Completed Phase 1 Results

• 2 other identifiers: 1320.132013-003580-62
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• TOTPAR0-8h

  up to 8 hours post drug administration

• SPID0-2h

  up to 2 hours post drug administration

• Time to Meaningful Pain Relief

  up to 10 hours post drug administration

• Time to First Dose of Rescue Medication

  up to 10 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

Study Arms (4)

BI 1026706 low dose

EXPERIMENTAL

BI 1026706 low dose

Drug: Placebo to BI 1026706 solution; Drug: BI 1026706; Drug: Placebo to BI 1026706 tablet

BI 1026706 high dose

EXPERIMENTAL

BI 1026706 high dose

Drug: BI 1026706; Drug: Placebo to BI 1026706 tablet

Placebo reference

EXPERIMENTAL

Placebo reference

Drug: Placebo to BI 1026706 solution; Drug: Placebo to BI 1026706 tablet

Celecoxib reference

EXPERIMENTAL

Celecoxib capsule

Drug: Placebo to BI 1026706 solution; Drug: Celecoxib

Interventions

Placebo to BI 1026706 solution DRUG

Placebo to BI 1026706 solution

BI 1026706 low dose; Celecoxib reference; Placebo reference

BI 1026706 DRUG

BI 1026706

BI 1026706 high dose; BI 1026706 low dose

Placebo to BI 1026706 tablet DRUG

Placebo to BI 1026706 tablet

BI 1026706 high dose; BI 1026706 low dose; Placebo reference

Celecoxib DRUG

Celecoxib capsule

Celecoxib reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

1320.13.39001 Boehringer Ingelheim Investigational Site

Verona, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: March 12, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: April 12, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04

Locations

IT (1)