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

NCT01900795 | Terminated Phase 2 DMC

• 1 other identifier: OAG2001
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• 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

Study Arms (3)

V117957

EXPERIMENTAL

Drug: V117957

Ibuprofen

ACTIVE COMPARATOR

Drug: Ibuprofen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

V117957 DRUG

V117957 4.5 mg suspension taken orally after surgery.

V117957

Ibuprofen DRUG

Ibuprofen 400 mg tablets taken orally after surgery.

Ibuprofen

Placebo DRUG

Placebo taken orally after surgery.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Purdue Pharma LP: lead

Study Sites (1)

PPD Dental Pain Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 16, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

US (1)