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

December 3, 2013 updated by: Purdue Pharma LP

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
114

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total pain relief 0 to 8 hours after dosing (TOTPAR8)
Time Frame: 0 - 8 hours postdose
Time-weighted sum of pain relief scores 0 to 8 hours after dosing
0 - 8 hours postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Total Pain Relief 0 - 4 hours after dosing (TOTPAR4)
Time Frame: Hour 4 postdose
Hour 4 postdose
Total Pain Relief 0 - 6 hours after dosing (TOTPAR6)
Time Frame: Hour 6 postdose
Hour 6 postdose
Total Pain Relief 0 - 12 hours after dosing (TOTPAR12)
Time Frame: Hour 12 postdose
Hour 12 postdose
Total Pain Relief 0 - 24 hours after dosing (TOTPAR24)
Time Frame: Hour 24 postdose
Hour 24 postdose
Pain Relief (PR) over time
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Pain intensity difference over time
Time Frame: 15, 30, 45 , 60, 90 minutes; 2, 3, 4, 4.5, 6, 8, 10, 12 and 24 hours postdose
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)
Time Frame: Hour 4 postdose
Hour 4 postdose
Sum of pain intensity difference 0 to 6 hours after dosing (SPID6)
Time Frame: Hour 6 postdose
Hour 6 postdose
Sum of pain intensity difference 0 to 8 hours after dosing (SPID8)
Time Frame: Hour 8 postdose
Hour 8 postdose
Sum of pain intensity difference 0 to 12 hours after dosing (SPID12)
Time Frame: Hour 12 postdose
Hour 12 postdose
Sum of pain intensity difference 0 to 24 hours after dosing (SPID24)
Time Frame: Hour 24 postdose
Hour 24 postdose
Time to first perceptible PR
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Time to meaningful PR
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Time to first use of rescue pain medication
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Proportion of subjects taking rescue medication by time point
Time Frame: Up to 24 hours postdose
Up to 24 hours postdose
Global assessment of overall satisfaction
Time Frame: Hour 24 postdose
Hour 24 postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Purdue Pharma LP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OAG2001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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