An Analgesic Study to of V117957 for the Treatment of Postsurgical Pain Due to Third Molar Extraction

Study Overview
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Brief Summary
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The primary objective of this study is to assess the analgesic properties of an oral dose of V117957 4.5 mg aqueous suspension in the third molar extraction model

Official Title
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A Phase 2a, Single-Center, Randomized, Double-Blind, Double- Dummy, Placebo- and Active-Controlled Analgesic Study of an Oral Dose of V117957 4.5 mg for the Treatment of Postsurgical Pain Due to Third Molar Extraction

Conditions
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Postsurgical Pain Due to Third Molar Extraction

Intervention / Treatment
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* Drug: V117957
* Drug: Ibuprofen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include: Males aged 18 to 45 years; Females aged 18 to 45 years of nonchildbearing potential; A body mass index of 18 to 30.0 kg/m2, inclusive; Scheduled to undergo outpatient surgical extraction of 2 or more third molars (with at least 1 partial bony mandibular extraction); Experience moderate to severe pain; Use only topical benzocaine, 2% lidocaine with epinephrine, and nitrous oxide as preoperative medication; Are deemed by the investigator to be appropriate candidates for the protocol-specified therapeutic regimen. Exclusion Criteria include: Are female who are pregnant, lactating or of child-bearing potential, or who have a positive pregnancy test result at screening or check-in; A history or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion; A history of frequent nausea or emesis regardless of etiology; A history of seizures or head trauma with sequelae; A cardiovascular disorder, including hypertension, unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure or active myocardial ischemia; A history of alcohol or substance abuse or addiction; A history of opioid abuse or addiction; A positive urine drug or alcohol test at screening or check-in; A positive urine cotinine test result at screening or check-in, smokes frequently (>1 time per week) or have used tobacco or nicotine substitutes within 1 month before the loading dose of study drug, and/or have an inability to refrain from use of nicotine between check-in and the follow-up visit; Ingest xanthine- or caffeine-containing foods or beverages (eg, coffee, tea, chocolate, and colas) within 24 hours before the loading dose of study drug and for the duration of confinement to the clinical site; Have the presence or history (within 2 years of screening) of bleeding disorder(s) or peptic ulcer disease; Have donated or lost ≥ 500 mL of blood in the 60 days before screening; Use of any medication, other than those that are standard for dental surgery; Have used acetaminophen, ibuprofen, aspirin, or other nonsteroidal anti-inflammatory drugs or any other analgesics (OTC or prescription) within 3 days before surgery; or have used long-acting anesthetics (eg, bupivacaine) or any other medications that may result in prolonged anesthesia, analgesia, or sedation; Have presence of a chronic or acute painful condition, other than the study indication, which could interfere with the assessment of efficacy of the study drug or any other condition that, in the opinion of the investigator, would adversely affect the subject's ability to complete the study or its measures; Are unsuitable to participate in this study for any other reason, in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V117957<br> | Drug: V117957<br>* V117957 4.5 mg suspension taken orally after surgery.<br>|
| Active Comparator: Ibuprofen<br> | Drug: Ibuprofen<br>* Ibuprofen 400 mg tablets taken orally after surgery.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo taken orally after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total pain relief 0 to 8 hours after dosing (TOTPAR8) | Time-weighted sum of pain relief scores 0 to 8 hours after dosing | 0 - 8 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Pain Relief 0 - 4 hours after dosing (TOTPAR4) |  | Hour 4 postdose | 
| Total Pain Relief 0 - 6 hours after dosing (TOTPAR6) |  | Hour 6 postdose | 
| Total Pain Relief 0 - 12 hours after dosing (TOTPAR12) |  | Hour 12 postdose | 
| Total Pain Relief 0 - 24 hours after dosing (TOTPAR24) |  | Hour 24 postdose | 
| Pain Relief (PR) over time |  | Up to 24 hours postdose | 
| Pain intensity difference over time |  | 15, 30, 45 , 60, 90 minutes; 2, 3, 4, 4.5, 6, 8, 10, 12 and 24 hours postdose | 
| Sum of pain intensity difference 0 to 4 hours after dosing (SPID4) |  | Hour 4 postdose | 
| Sum of pain intensity difference 0 to 6 hours after dosing (SPID6) |  | Hour 6 postdose | 
| Sum of pain intensity difference 0 to 8 hours after dosing (SPID8) |  | Hour 8 postdose | 
| Sum of pain intensity difference 0 to 12 hours after dosing (SPID12) |  | Hour 12 postdose | 
| Sum of pain intensity difference 0 to 24 hours after dosing (SPID24) |  | Hour 24 postdose | 
| Time to first perceptible PR |  | Up to 24 hours postdose | 
| Time to meaningful PR |  | Up to 24 hours postdose | 
| Time to first use of rescue pain medication |  | Up to 24 hours postdose | 
| Proportion of subjects taking rescue medication by time point |  | Up to 24 hours postdose | 
| Global assessment of overall satisfaction |  | Hour 24 postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postsurgical pain