Dental PainPhase 2NCT02161354

Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars

A Phase 2 study testing NTC-510 capsules and NTC-510A Capsules in people with Dental Pain, run by NanoSHIFT LLC at 1 site in United States.

Terminated

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

Official record

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Trial summary

To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Dental Pain
What is being tested?: NTC-510 capsules and NTC-510A Capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Jun 2014to Feb 2016
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

Subject is able to read, understand, and sign the approved informed consent form.
Subject is an adult between 18 and 45 years of age, inclusive, who has been evaluated and scheduled for an elective third molar surgical extraction (targeting 1 or 2 third molars, at least 1 of which is mandibular and fully or partially impacted by bone). Supernumerary or affected adjacent teeth may be removed at the surgeon's discretion.
Subject has body mass index of 18.0 to 30.0 kg/m2, inclusive.
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device (copper/hormonal), NuvaRing®, Depo-Provera®, or double-barrier method, and have a negative pregnancy test prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy.
Subject must experience moderate to severe pain (i.e., rating of 2 or 3 on a 4-point categorical PI scale [0 = none, 1 = mild, 2 = moderate, and 3 = severe] and a score of ≥ 50 mm on a 100 mm VAS) within 5 hours after the dental extraction.
Subject has been administered only 2% topical benzocaine, lidocaine with epinephrine, and/or nitrous oxide as preoperative medication.
Subject is determined by the investigator to be otherwise in good health and unlikely to be at risk from participation in this study.

Who cannot join

Female subject who is pregnant or lactating.
Subject has a history of human immunodeficiency virus, hepatitis B, or hepatitis C infection.
Subject has participated in any clinical research study within the previous 8 weeks.
Subject has a history of seizures and/or significant head trauma.
Subject has an abnormal cardiac condition including any of the following:
Medically significant disorders of cardiac rate and/or rhythm

Show all 22Show fewer

QTc interval > 450 msec (calculated using Fridericia's correction) or uncorrected QT interval > 500 msec, PR interval > 240 msec or ≤ 110 msec, evidence of second or third degree atrioventricular block, pathological Q-waves (defined as Q-wave > 40 msec or depth > 0.5 mV), evidence of ventricular pre-excitation, complete left bundle branch block, and/or resting heart rate outside the range of 40 to 120 beats per minute
Subject has evidence of clinically significant abnormal laboratory values including the following:
Impaired kidney function (i.e., serum creatinine ≥ 1.5 mg/dL)
Impaired liver function (laboratory test values ≥ 3 times the upper limit of normal [ULN] for aspartate aminotransferase or alanine aminotransferase, or values > 2 times the ULN for alkaline phosphatase), or total bilirubin level > 1.5 times the ULN or, in the opinion of the investigator, liver function impairment to the extent that the subject should not participate in this study
Presence of Gilbert's Syndrome or any known hepatobiliary abnormalities
Any other laboratory values judged as clinically significant by the investigator
Subject has a history of chronic or sustained intake of opioid drugs in the preceding 12 months, or has taken any medication containing opioid compounds in the month preceding entry to this trial.
Subject has a history of alcohol or substance abuse or addiction within 2 years before screening and/or routine consumption of 3 or more alcohol-containing beverages per day. Subject has consumed alcohol within 3 days before administration of study drug or cannot abstain for the duration of confinement to the clinical unit.
Subject has a prior history of intolerance to opioid drugs, their excipients, or related compounds.
Subject has positive urine test for alcohol, cotinine, or drugs of abuse at screening or check-in. If a subject is excluded for a positive drug screen due to prescribed medication for pain from an infected molar, the subject may be rescreened after the appropriate washout period.
Subject has used any medication (with the exception of vitamins and contraceptives), including over-the-counter medications, herbal and/or mineral supplements, dietary supplements, or has ingested grapefruit-containing foods or beverages within 3 days before administration of study drug, or cannot abstain for the duration of confinement to the clinical unit.
Subject has ingested caffeine-containing foods or beverages (e.g., coffee, tea, chocolate, and colas) within 24 hours before administration of study drug or cannot abstain for the duration of confinement to the clinical unit.
Subject has smoked or used other nicotine products within 3 days before study drug administration or cannot abstain for the duration of confinement to the clinical unit.
Subject has the presence of any conditions possibly affecting drug absorption (e.g., gastrectomy or malabsorption) or has taken oral medications that affect gastric acid availability (including H2 antagonists, proton-pump inhibitors, and antacids) within 3 days before administration of study drug.
Subject has any current dental or medical condition that could prevent safe participation in this study.
Subject has significant medical or psychiatric symptoms, cognitive impairment, or other factors which, in the opinion of the investigator, would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent.

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 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study To Determine The Efficacy and Safety of Buprenorphine (as NTC-510 and NTC-510A) in Subjects With Pain Following Surgical Extraction of 1 or 2 Third Molars.

To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction.

Read the detailed description

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, concentration versus efficacy relationship, and safety of NTC-510 and NTC-510A at doses of 2.0, 1.0, and 0.5 mg.

The study will consist of 4 phases: screening (within 28 days before check-in), check-in (before surgery on Day 1), treatment (surgery, randomization, and treatment with study drug on Day 1), and follow up (Days 6 to 8). During the screening phase, screening procedures will be performed, subject eligibility will be determined, and written consent will be obtained. Subjects will then undergo dental surgery to extract 1 or 2 third molars (with at least 1 partial or complete bony mandibular extraction). The impaction score ([1] erupted in tissue, [2] broken soft tissue, [3] partial bony impaction, and [4] full bony impaction) will be collected for statistical adjustment should there be randomization imbalance. The surgery will be conducted according to standard clinical unit procedures.

Conditions: Dental Pain
Being tested: NTC-510 capsules, Placebo Capsules, NTC-510A Capsules
Keywords: Dental Pain, Acute Pain, Mild Pain, Moderate Pain
Medical subject headings: Toothache, Acute Pain

What participants receive

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

NTC-510 capsulesDrug
Also called buprenorphine and naloxone capsules
Subjects will be randomized to one of 3 groups and NTC-510 will be given as a single oral dose of 2.0 mg, a split dose of 2.0 mg followed by 2.0 mg an hour later, or 6.0 mg for acute pain relief (PR) following third molar extraction.
Placebo CapsulesDrug
Also called placebo capsule
Subjects will be randomized to one of 3 groups and placebo capsules will be given as a single oral dose of for acute dental pain following third molar extraction.
NTC-510A CapsulesDrug
Also called buprenorphine capsules
Subjects will be randomized to one of 3 groups where NTC-510A or placebo will be given as a single oral dose of 2.0, 4.0, or 6 mg for acute pain relief (PR) following third molar extraction

Study groups in NCT02161354
Study group	Role	What they receive
2mg dose of NTC-510 or placebo	Experimental	Subjects will be dosed with 2 mg of NTC-510 or placebo. Receives: Drug: NTC-510 capsules; Drug: Placebo Capsules
4 mg dose of NTC-510 or placebo	Experimental	Subjects will be dosed as a split dose of 2 mg followed by 2 mg an hour later of NTC-510 or placebo. Receives: Drug: NTC-510 capsules; Drug: Placebo Capsules
6 mg dose of NTC-510 or placebo	Experimental	Subjects will be dosed with 6 mg of NTC-510 or placebo. Receives: Drug: NTC-510 capsules; Drug: Placebo Capsules
2 mg dose of NTC-510, NTC-510A or placebo	Experimental	Subjects will be dosed with 2mg of NTC-510A or placebo Receives: Drug: NTC-510 capsules; Drug: Placebo Capsules; Drug: NTC-510A Capsules
4 mg dose of NTC-510, NTC-510A or placebo	Experimental	Subjects will be dosed with 4 mg of NTC-510A or placebo Receives: Drug: NTC-510 capsules; Drug: Placebo Capsules; Drug: NTC-510A Capsules
6 mg dose of NTC-510, NTC-510A or placebo	Experimental	Subjects will be dosed with 6 mg of NTC-510A or placebo Receives: Drug: NTC-510 capsules; Drug: Placebo Capsules; Drug: NTC-510A Capsules

What is being measured

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

Decrease in dental pain when taking a single doses of NTC-510 or NTC-510A at 2.0, 1.0, or 0.5 mg following third molar extraction.
Measured: 24 hours

Secondary outcomes (1)

Evaluate the number of subjects with adverse events following a single oral dose of 2.0, 1.0, or 0.5 mg for acute pain relief (PR) following third molar extraction
Measured: 24 hours

Timeline

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

Jun 2014Feb 2016

First posted11 Jun 2014 (estimated)
Study startJun 2014
Primary completionFeb 2016
Study completionFeb 2016

Why it stopped: safety and efficacy after cohort 5 did not warrant further dose escalation

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dental PainStudies 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: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02161354
Sponsor's protocol ID: NTC-510-004
Status last verified: Jun 2017
First submitted: 6 Jun 2014
Last updated: 23 Jun 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dental Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study To Determine The Efficacy and Safety of Buprenorphine (as NTC-510 and NTC-510A) in Subjects With Pain Following Surgical Extraction of 1 or 2 Third Molars.
ClinicalTrials.gov ID: NCT02161354
Acronym / sponsor ID: NTC-510-004
Conditions: Dental Pain
Keywords: Dental Pain, Acute Pain, Mild Pain, Moderate Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: safety and efficacy after cohort 5 did not warrant further dose escalation
Enrolment: 52 participants (actual)
Lead sponsor: NanoSHIFT LLCIndustry (pharma, biotech, devices)
Study start: Jun 2014
Primary completion: Feb 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 11 Jun 2014 (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.

To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
2mg dose of NTC-510 or placebo	Experimental	Drug: NTC-510 capsules, Drug: Placebo CapsulesSubjects will be dosed with 2 mg of NTC-510 or placebo.
4 mg dose of NTC-510 or placebo	Experimental	Drug: NTC-510 capsules, Drug: Placebo CapsulesSubjects will be dosed as a split dose of 2 mg followed by 2 mg an hour later of NTC-510 or placebo.
6 mg dose of NTC-510 or placebo	Experimental	Drug: NTC-510 capsules, Drug: Placebo CapsulesSubjects will be dosed with 6 mg of NTC-510 or placebo.
2 mg dose of NTC-510, NTC-510A or placebo	Experimental	Drug: NTC-510 capsules, Drug: Placebo Capsules, Drug: NTC-510A CapsulesSubjects will be dosed with 2mg of NTC-510A or placebo
4 mg dose of NTC-510, NTC-510A or placebo	Experimental	Drug: NTC-510 capsules, Drug: Placebo Capsules, Drug: NTC-510A CapsulesSubjects will be dosed with 4 mg of NTC-510A or placebo
6 mg dose of NTC-510, NTC-510A or placebo	Experimental	Drug: NTC-510 capsules, Drug: Placebo Capsules, Drug: NTC-510A CapsulesSubjects will be dosed with 6 mg of NTC-510A or placebo

Who may qualify

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

Key inclusion criteria (7 listed)

Subject is able to read, understand, and sign the approved informed consent form.
Subject is an adult between 18 and 45 years of age, inclusive, who has been evaluated and scheduled for an elective third molar surgical extraction (targeting 1 or 2 third molars, at least 1 of which is mandibular and fully or partially impacted by bone). Supernumerary or affected adjacent teeth may be removed at the surgeon's discretion.
Subject has body mass index of 18.0 to 30.0 kg/m2, inclusive.
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device (copper/hormonal), NuvaRing®, Depo-Provera®, or double-barrier method, and have a negative pregnancy test prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or have had a hysterectomy and/or bilateral oophorectomy.
Subject must experience moderate to severe pain (i.e., rating of 2 or 3 on a 4-point categorical PI scale [0 = none, 1 = mild, 2 = moderate, and 3 = severe] and a score of ≥ 50 mm on a 100 mm VAS) within 5 hours after the dental extraction.

Key exclusion criteria (22 listed)

Female subject who is pregnant or lactating.
Subject has a history of human immunodeficiency virus, hepatitis B, or hepatitis C infection.
Subject has participated in any clinical research study within the previous 8 weeks.
Subject has a history of seizures and/or significant head trauma.
Subject has an abnormal cardiac condition including any of the following:

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
NTC-510 capsulesAlso: buprenorphine and naloxone capsulesSubjects will be randomized to one of 3 groups and NTC-510 will be given as a single oral dose of 2.0 mg, a split dose of 2.0 mg followed by 2.0 mg an hour later, or 6.0 mg for acute pain relief (PR) following third molar extraction.	Drug	2 mg dose of NTC-510, NTC-510A or placebo, 2mg dose of NTC-510 or placebo, 4 mg dose of NTC-510 or placebo, 4 mg dose of NTC-510, NTC-510A or placebo, 6 mg dose of NTC-510 or placebo, 6 mg dose of NTC-510, NTC-510A or placebo
Placebo CapsulesAlso: placebo capsuleSubjects will be randomized to one of 3 groups and placebo capsules will be given as a single oral dose of for acute dental pain following third molar extraction.	Drug	2 mg dose of NTC-510, NTC-510A or placebo, 2mg dose of NTC-510 or placebo, 4 mg dose of NTC-510 or placebo, 4 mg dose of NTC-510, NTC-510A or placebo, 6 mg dose of NTC-510 or placebo, 6 mg dose of NTC-510, NTC-510A or placebo
NTC-510A CapsulesAlso: buprenorphine capsulesSubjects will be randomized to one of 3 groups where NTC-510A or placebo will be given as a single oral dose of 2.0, 4.0, or 6 mg for acute pain relief (PR) following third molar extraction	Drug	2 mg dose of NTC-510, NTC-510A or placebo, 4 mg dose of NTC-510, NTC-510A or placebo, 6 mg dose of NTC-510, NTC-510A or placebo

Primary outcome

Decrease in dental pain when taking a single doses of NTC-510 or NTC-510A at 2.0, 1.0, or 0.5 mg following third molar extraction.
Time frame: 24 hours

1 secondary outcome

Evaluate the number of subjects with adverse events following a single oral dose of 2.0, 1.0, or 0.5 mg for acute pain relief (PR) following third molar extraction
Time frame: 24 hours

Results and safety

The study was stopped early (reason given: safety and efficacy after cohort 5 did not warrant further dose escalation). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
Individual participant dataSharing planned: Undecided

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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.

William L Buchanan, MD,DDS principal investigator

PPD Development, LP

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 NTC-510 capsules and NTC-510A Capsules in people with Dental Pain, run by NanoSHIFT LLC 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 22 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 23 Jun 2017. 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. 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: safety and efficacy after cohort 5 did not warrant further dose escalation). 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?

Decrease in dental pain when taking a single doses of NTC-510 or NTC-510A at 2.0, 1.0, or 0.5 mg following third molar extraction. (time frame: 24 hours). 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 NCT02161354.

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 23 Jun 2017.