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

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)

To investigate the effectiveness of BI 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to Celecoxib.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Placebo to BI 1026706 solution; Drug: BI 1026706; Drug: Placebo to BI 1026706 tablet; Drug: Celecoxib

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 1

Contacts and Locations

Study Locations

• Italy
  • Verona, Italy
    • 1320.13.39001 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 1026706 low dose	Drug: Placebo to BI 1026706 solution; Placebo to BI 1026706 solution; Drug: BI 1026706; BI 1026706; Drug: Placebo to BI 1026706 tablet; Placebo to BI 1026706 tablet
Experimental: BI 1026706 high dose	Drug: BI 1026706; BI 1026706; Drug: Placebo to BI 1026706 tablet; Placebo to BI 1026706 tablet
Experimental: Placebo reference	Drug: Placebo to BI 1026706 solution; Placebo to BI 1026706 solution; Drug: Placebo to BI 1026706 tablet; Placebo to BI 1026706 tablet
Experimental: Celecoxib reference; Celecoxib capsule	Drug: Placebo to BI 1026706 solution; Placebo to BI 1026706 solution; Drug: Celecoxib; Celecoxib capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 10, 2014
• First Submitted That Met QC Criteria: March 10, 2014
• First Posted (Estimate): March 12, 2014

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 1320.13; 2013-003580-62 (EudraCT Number: EudraCT)