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

NCT ID: NCT01900795

Last Updated: 2013-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2013-11-30

Brief Summary

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

Conditions

Postsurgical Pain Due to Third Molar Extraction

Keywords

Postsurgical pain

Study Design

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

Study Groups

V117957

Group Type: EXPERIMENTAL

V117957

Intervention Type: DRUG

V117957 4.5 mg suspension taken orally after surgery.

Ibuprofen

Group Type: ACTIVE_COMPARATOR

Ibuprofen

Intervention Type: DRUG

Ibuprofen 400 mg tablets taken orally after surgery.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo taken orally after surgery.

Interventions

V117957

V117957 4.5 mg suspension taken orally after surgery.

Intervention Type: DRUG

Ibuprofen

Ibuprofen 400 mg tablets taken orally after surgery.

Intervention Type: DRUG

Placebo

Placebo taken orally after surgery.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Purdue Pharma LP

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PPD Dental Pain Clinic

Austin, Texas, United States

Countries

United States

Other Identifiers

OAG2001

Identifier Type: -

Identifier Source: org_study_id