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

NCT02161354 | Terminated Phase 2

• 1 other identifier: NTC-510-004
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Pain

Keywords

Dental Pain; Acute Pain; Mild Pain; Moderate Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  24 hours

Study Arms (6)

2mg dose of NTC-510 or placebo

EXPERIMENTAL

Subjects will be dosed with 2 mg of NTC-510 or placebo.

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.

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.

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

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

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

Drug: NTC-510 capsules; Drug: Placebo Capsules; Drug: NTC-510A Capsules

Interventions

NTC-510 capsules DRUG

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.

Also known as: buprenorphine and naloxone capsules

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 Capsules DRUG

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.

Also known as: placebo capsule

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 Capsules DRUG

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

Also known as: buprenorphine capsules

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

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NanoSHIFT LLC: lead

Study Sites (1)

PPD Dental Pain Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Toothache; Acute Pain

Interventions

Buprenorphine; Naloxone

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• William L Buchanan, MD,DDS

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 11, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

US (1)