Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia
Condition: Diagnostic; Procedures and Surgeries on or Through Accessible Mucous Membranes; of the Nasal Cavities
Intervention: Cocaine HCl 4% Topical Solution; Cocaine HCl 10% Topical Solution; Placebo Topical Solution
Intervention description: Cocaine HCl 4% Topical Solution; Cocaine HCl 10% Topical Solution; Placebo Topical Solution
Intervention MeSH terms: Cocaine; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Surgery; Surgeries; Nasal; Cavities; Diagnosis; Diagnostic; Nose; Rhinoplasty; Endoscopy; Bronchoscopy

Summary:

      This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and
      efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through
      accessible mucous membranes of the nasal cavities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent and HIPAA authorization. Residents of California must
             also review and sign the California Subject Bill of Rights.

          -  Male or female ≥18 years of age.

          -  Predetermined need from a physician for a diagnostic procedure or surgery of or
             through the nasal mucous membranes of either one or two nostrils.

          -  Ability to feel pain sensation normally in the nasal mucous membranes, as verified via
             Von Frey 5.18 monofilament testing.

          -  Ability to clearly communicate pain and sensation of the nasal mucous membranes.

        Exclusion Criteria:

          -  Has a known allergy to any ester based anesthetics including cocaine HCl, procaine,
             tetracaine, chloroprocaine, dibucaine, or benzocaine, and/or any other compounds of
             the drugs and/or devices that are part of this protocol. (Amide based anesthetic
             allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine,
             Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prilocaine, and Articaine).

          -  Has a history of abuse of controlled substances, nasal or otherwise, or has damage to
             the nasal space that in the opinion of the investigator might interfere with the
             ability of the subject or the investigator to judge anesthesia from the trial drug.

          -  Has used any investigational drug(s) within 30 days preceding the randomization.

          -  Is pregnant or is a nursing mother

          -  Women of childbearing potential (WOCBP) and men must be using an acceptable method of
             contraception to avoid pregnancy throughout the study, and for women 30 days and men
             90 days after the last dose of investigational product in such a manner that the risk
             of pregnancy and risk to pregnancy is minimized.

          -  Is < 18 years of age

          -  Suffers from a condition, other than the need for a diagnostic procedure or surgery of
             or through the nasal mucous membranes which, in the opinion of the Investigator, would
             compromise the safety of the subject and/or the quality of the data, or the normal
             wound healing process.

          -  Use of any analgesic 2 days prior to screening or has a need to use these drugs during
             the screening period. This includes NSAID such as ibuprofen, diclofenac, indomethacin,
             sulindac, tolmetin, ketoprofen, flurbiprofen, naproxen, opioids such as codeine,
             hydrocodone, hydromorphone, morphine, oxycodone, aspirin, or acetaminophen.

          -  Subjects who have experienced a seizure while taking isoniazid (INH), phenothiazines,
             chlorpromazine, thioridazine, theophylline, or tricyclic antidepressants such as
             amitriptyline.

          -  Has previously received study drug during this study. Subjects who fail screening may
             rescreen if eligibility requirements are met.

          -  Has a history of myocardial infarction, coronary artery disease, congestive heart
             failure, irregular heart rhythm (as fully defined in sections 9.4, 9.5, and 9.6 of the
             protocol), or uncontrolled hypertension or is taking (or has recently taken) monoamine
             oxidase inhibitors. Uncontrolled hypertension is defined as systolic blood pressure
             greater than or equal to 140 mm Hg or diastolic blood pressure greater than or equal
             to 90 mm Hg

          -  Has a known personal or family history of hereditary pseudocholinesterase deficiency.
             Study participants will be screened by asking about personal or family history of
             anesthetic reaction, anesthetic death, and previous diagnosis of pseudocholinesterase
             deficiency in a relative or personally. Subjects identified with pseudocholinesterase
             deficiency are at risk for delayed recovery with certain anesthetics (e.g.
             succinylcholine and ester-based anesthetics).

          -  Has a known personal or family history of pheochromocytoma. Study participants will be
             specifically asked if they have been treated for a pheochromocytoma previously or if
             they have a family member who has been diagnosed with pheochromocytoma (since 10% of
             these are familial).

          -  Has a known personal or family history of an adrenal tumor.

          -  Use of amphetamines in the 2 days prior to screening or has a need to use these drugs
             during the course of the study. All stimulant prescription, and nonprescription
             products such as catecholamines (norepinephrine or epinephrine), ephedrine,
             pseudoephedrine and any other amphetamines in the 48 hours prior to screening or has a
             need to use these drugs during the course of the study. All herbal products are also
             prohibited within 48 hours prior to screening or if the subject has a need to use
             these drugs during the course of the study.

          -  Has screening 12-lead ECG findings of any abnormalities as listed in sections 7.9.4,
             7.9.5, and 7.9.6 of the protocol. Generally, these are current or prior myocardial
             ischemia or infarction, dysrhythmia, or risk of serious dysrhythmia (such as prolonged
             QT interval) An exception to this would be from 7.9.5.11 if sinus bradycardia or sinus
             tachycardia is present, the Investigator must determine whether this finding is
             clinically relevant and exclusionary.

          -  Hemoglobin <8.5 g/dL; a one-time retest will be allowed for Hb 8.3-8.4 g/dL

          -  WBC < 3.5 x 103 cells/mcL; a one-time retest will be allowed for WBC 3.3-3.4 x 103
             cells/mcL

          -  Platelets < 100 x 103 platelets/mcL; a one-time retest will be allowed for platelets
             90-99x 103 platelets/mcL

          -  Serum Potassium <3.5 or >4.5 mEq/L

          -  Serum ALT, AST, and bilirubin not exceeding 2X ULN for the lab's reference values

          -  Cardiac enzymes outside of the range of normal

          -  Coagulation studies that in the opinion of the investigator would be cause for the
             subject to be excluded from the study.

          -  Positive urine pregnancy test at screening or Day 1

          -  Positive urine drug test at screening or Day 1 without prior medically-necessary use
             of controlled substances (for example, benzodiazepines for anxiety)

          -  A one-time retest is permitted for any blood test if the original sample was
             hemolyzed.