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

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

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

Study Overview

• Status: Terminated
• Conditions: Postsurgical Pain Due to Third Molar Extraction
• Intervention / Treatment: Drug: V117957; Drug: Ibuprofen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Dental Pain Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo; Placebo taken orally after surgery.
ACTIVE_COMPARATOR: Ibuprofen	Drug: Ibuprofen; Ibuprofen 400 mg tablets taken orally after surgery.
EXPERIMENTAL: V117957	Drug: V117957; V117957 4.5 mg suspension taken orally after surgery.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Purdue Pharma LP

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (ESTIMATE): July 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Postsurgical pain
• 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; Ibuprofen
• Other Study ID Numbers: OAG2001