Overview
Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars
Status:
Terminated
Terminated
Trial end date:
2016-02-01
2016-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
NanoSHIFT LLC
Nanotherapeutics, Inc.Treatments:
Buprenorphine
Naloxone
Polystyrene sulfonic acid
Criteria
Inclusion Criteria:- 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.
Exclusion Criteria:
- 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
- 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.