Postsurgical Pain Due to Third Molar ExtractionPhase 2NCT01900795

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

A Phase 2 study testing V117957 and Ibuprofen in people with Postsurgical Pain Due to Third Molar Extraction, run by Purdue Pharma LP at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Postsurgical Pain Due to Third Molar Extraction
What is being tested?: V117957 and Ibuprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 114 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Nov 2013
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

PPD Dental Pain Clinic
Austin, Texas, 78744

Other trials in United States

About this study

Official title: 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

Conditions: Postsurgical Pain Due to Third Molar Extraction
Being tested: V117957, Ibuprofen, Placebo
Keywords: Postsurgical pain
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V117957Drug
V117957 4.5 mg suspension taken orally after surgery.
IbuprofenDrug
Ibuprofen 400 mg tablets taken orally after surgery.
PlaceboDrug
Placebo taken orally after surgery.

Study groups in NCT01900795
Study group	Role	What they receive
V117957	Experimental	Not described Receives: Drug: V117957
Ibuprofen	Active comparator	Not described Receives: Drug: Ibuprofen
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Total pain relief 0 to 8 hours after dosing (TOTPAR8)
Time-weighted sum of pain relief scores 0 to 8 hours after dosing
Measured: 0 - 8 hours postdose

Secondary outcomes (16)

Total Pain Relief 0 - 4 hours after dosing (TOTPAR4)
Measured: Hour 4 postdose
Total Pain Relief 0 - 6 hours after dosing (TOTPAR6)
Measured: Hour 6 postdose
Total Pain Relief 0 - 12 hours after dosing (TOTPAR12)
Measured: Hour 12 postdose
Total Pain Relief 0 - 24 hours after dosing (TOTPAR24)
Measured: Hour 24 postdose
Pain Relief (PR) over time
Measured: Up to 24 hours postdose
Pain intensity difference over time
Measured: 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)
Measured: Hour 4 postdose
Sum of pain intensity difference 0 to 6 hours after dosing (SPID6)
Measured: Hour 6 postdose
Sum of pain intensity difference 0 to 8 hours after dosing (SPID8)
Measured: Hour 8 postdose
Sum of pain intensity difference 0 to 12 hours after dosing (SPID12)
Measured: Hour 12 postdose
Sum of pain intensity difference 0 to 24 hours after dosing (SPID24)
Measured: Hour 24 postdose
Time to first perceptible PR
Measured: Up to 24 hours postdose
Time to meaningful PR
Measured: Up to 24 hours postdose
Time to first use of rescue pain medication
Measured: Up to 24 hours postdose
Proportion of subjects taking rescue medication by time point
Measured: Up to 24 hours postdose
Global assessment of overall satisfaction
Measured: Hour 24 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Nov 2013

First posted16 Jul 2013 (estimated)
Study startJul 2013
Primary completionNov 2013
Study completionNov 2013

Why it stopped: Terminated early due to administrative reasons not related to safety.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Postsurgical Pain Due to Third Molar ExtractionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900795
Sponsor's protocol ID: OAG2001
Status last verified: Dec 2013
First submitted: 12 Jul 2013
Last updated: 5 Dec 2013
Results posted: No
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01900795
Acronym / sponsor ID: OAG2001
Conditions: Postsurgical Pain Due to Third Molar Extraction
Keywords: Postsurgical pain
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Terminated early due to administrative reasons not related to safety.
Enrolment: 114 participants (actual)
Lead sponsor: Purdue Pharma LPIndustry (pharma, biotech, devices)
Study start: Jul 2013
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 16 Jul 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
V117957	Experimental	Drug: V117957
Ibuprofen	Active comparator	Drug: Ibuprofen
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (7 listed)

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;

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V117957V117957 4.5 mg suspension taken orally after surgery.	Drug	V117957
IbuprofenIbuprofen 400 mg tablets taken orally after surgery.	Drug	Ibuprofen
PlaceboPlacebo taken orally after surgery.	Drug	Placebo

Primary outcome

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

16 secondary outcomes

Total Pain Relief 0 - 4 hours after dosing (TOTPAR4)
Time frame: Hour 4 postdose
Total Pain Relief 0 - 6 hours after dosing (TOTPAR6)
Time frame: Hour 6 postdose
Total Pain Relief 0 - 12 hours after dosing (TOTPAR12)
Time frame: Hour 12 postdose
Total Pain Relief 0 - 24 hours after dosing (TOTPAR24)
Time frame: Hour 24 postdose
Pain Relief (PR) over time
Time frame: 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
Sum of pain intensity difference 0 to 4 hours after dosing (SPID4)
Time frame: Hour 4 postdose
Sum of pain intensity difference 0 to 6 hours after dosing (SPID6)
Time frame: Hour 6 postdose
Sum of pain intensity difference 0 to 8 hours after dosing (SPID8)
Time frame: Hour 8 postdose
Sum of pain intensity difference 0 to 12 hours after dosing (SPID12)
Time frame: Hour 12 postdose
Sum of pain intensity difference 0 to 24 hours after dosing (SPID24)
Time frame: Hour 24 postdose
Time to first perceptible PR
Time frame: Up to 24 hours postdose
Time to meaningful PR
Time frame: Up to 24 hours postdose
Time to first use of rescue pain medication
Time frame: Up to 24 hours postdose
Proportion of subjects taking rescue medication by time point
Time frame: Up to 24 hours postdose
Global assessment of overall satisfaction
Time frame: Hour 24 postdose

Results and safety

The study was stopped early (reason given: Terminated early due to administrative reasons not related to safety.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2013.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing V117957 and Ibuprofen in people with Postsurgical Pain Due to Third Molar Extraction, run by Purdue Pharma LP at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated early due to administrative reasons not related to safety.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total pain relief 0 to 8 hours after dosing (TOTPAR8) (time frame: 0 - 8 hours postdose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01900795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2013.