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A Phase III Investigation of 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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes, of the Nasal Cavities.

Thank you

Trial Information

A Phase III Investigation of 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.


Randomized, prospective, multi-site, double-blind, placebo-controlled, parallel-group study
of a Placebo Topical Solution versus Cocaine HCl 4% or 10% Topical Solution as an anesthetic
prior to a 1 (one) day diagnostic procedure or surgery. Subjects will be randomized in a
1:1:1 fashion to one of the three treatment groups (placebo, 4% or 10%) pre-procedure and
given up to two applications of the assigned test product. After pre-procedure Von Frey
filament testing, the blind will be broken, but only relative to placebo versus cocaine, not
relative to the strength of the cocaine. The placebo subjects will then exit participation
in the efficacy portion of the trial at that point, and be followed for safety for 7 (seven)
days.


Inclusion Criteria:



- Provide written informed consent and HIPAA authorization. Residents of California
must also review and sign the Subject Bill of Rights.

- Male or female ≥18 years of age.

- Predetermined need from a physician for diagnostic procedure or surgery on 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 5.18 monofilament testing

- Ability to clearly communicate pain and sensation of the nasal mucous membranes.

Exclusion Criteria:

- Has a known allergy to cocaine HCl, and/or any other compounds of the drugs and/or
devices that are part of this protocol.

- 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 or
the physician or subject anticipates use of any of these therapies during the first
20 weeks following start of the treatment portion of the study.

- 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 up to 8 days after the
last dose of investigational product in such a manner that the risk of pregnancy is
minimized.

- Is < 18 years of age

- Suffers from a condition, other than the need for a diagnostic procedure or surgery
on or through the nasal mucous membranes which, in the opinion of the Investigator,
would compromise the safety of the subject, 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 includesNSAIDs, 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)or
uncontrolled hypertension or istaking monoamine oxidase inhibitors (6).

- Has a known personal or family history of hereditary pseudocholinesterase deficiency.
(2) 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 malignant hyperthermia with
certain anesthetics (e.g. succinylcholine) and are questioned about history of fever
with anesthesia. (14)

- Has a known personal or family history of pheochromocytoma. (2) 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). (14)

- 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 EKG findings of any abnormalities as listed in 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 resting sinus bradycardia or resting sinus tachycardia to a limit of 110
beats per minute) as these represent normal variants that may be found in younger or
older healthy adults.

- 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/L a one-time retest will be allowed for WBC 3.3-3.4 x 103
cells/L

- Platelets < 100 x 103 cells/L; a one-time retest will be allowed for platelets 90-99x
103 cells/L

- Serum Potassium <3.5 or >4.5

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Analgesic Success

Outcome Description:

The primary endpoint for this trial is analgesic success immediately after application and sustained throughout the diagnostic procedure or surgery. A subject will be considered a treatment success if they meet the following: Prior to the procedure or surgery, a 0 pain score on the 10 point pain scale (0=no pain, 10=unbearable pain) based on the Von Frey filament challenge after either the first or second application of the assigned treatment solution (placebo, 4% or 10% Cocaine HCl) During the procedure or surgery, no further analgesic treatment is required.

Outcome Time Frame:

Prior to and During a one-day Surgery or Diagnostic Procedure

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

Protocol COCA4vs10-001

NCT ID:

NCT01746940

Start Date:

January 2013

Completion Date:

December 2013

Related Keywords:

  • Diagnostic
  • Procedures and Surgeries on or Through Accessible Mucous Membranes
  • of the Nasal Cavities.
  • Surgery
  • Surgeries
  • Nasal
  • Cavities
  • Diagnosis
  • Diagnostic
  • Nose
  • Rhinoplasty
  • Endoscopy
  • Bronchoscopy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous

Name

Location

Research Across AmericaCarrollton, Texas  75010