Topical Application of Cocaine HCl 4%, or 10%, or Placebo Solution in Local (Topical) Anesthesia

NCT02500836 | Completed Phase 3 Results

• 1 other identifier: COCA4vs10-002
• Study Type: interventional
• Target: 646
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, prospective, multi-center, double blind placebo-controlled parallel group study of a Placebo Topical Solution versus Cocaine HCl 4% Topical Solution for safety and efficacy, and Cocaine HCl 4% and 10% Topical Solution for Safety as an anesthetic prior to a diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities. Both domestic (United States) and foreign sites are eligible, and both inpatient and outpatient settings are eligible.

Conditions

Any Ear Nose or Throat Conditions; With Identified Need for a Diagnostic Procedure or Surgery on or Through the Mucous Membranes of the Nasal Cavities

Keywords

Ear; Nose; Throat

Outcome Measures

Primary Outcomes (1)

• Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution

  Subjects who meet the following for each nostril that received the study drug application are considered a treatment success: Prior to the diagnostic procedure or surgery, based on the von Frey monofilament test, after application of the assigned study drug solution (Cocaine HCl 4% Topical Solution or Placebo Topical Solution), the subject response is a 0 (zero) pain score on the 11 point pain scale (0 = no pain, 10 = unbearable pain) compared to the von Frey monofilament test right before study drug application. And, during the diagnostic procedure or surgery, no further analgesic treatment is required (only 4% Cocaine HCl subjects who receive a diagnostic procedure or surgery). Subjects with missing primary outcome data are marked as treatment failures in both treatment groups.

  One Day, Single office based diagnostic procedure or surgery

Secondary Outcomes (1)

• Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution

  One Day, Single office based diagnostic procedure or surgery

Study Arms (3)

Cocaine HCI 4% Topical Solution

EXPERIMENTAL

Cocaine HCl 4% Topical Solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.88, about 60 grams of force) to determine and record whether the subject has a pain score of 0 (zero) (0 = No Pain, 10 = Unbearable pain) after treatment application compared to the Von Frey filament test right before treatment application. If a pain score of 0 (zero) is recorded, then the diagnostic procedure or surgery proceeds along with safety monitoring for at least 90 minutes after removal of the pledget(s). The subject will be followed for safety for seven days. The total number of pledgets used, and the amount of Cocaine HCl 4% topical solution used (1 mL per pledget) will be recorded.

Drug: Cocaine HCl 4% Topical Solution

Cocaine HCI 10% Topical Solution

EXPERIMENTAL

Cocaine HCl 10% Topical Solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.88, about 60 grams of force) to determine and record whether the subject has a pain score of 0 (zero) (0 = No Pain, 10 = Unbearable pain) after treatment application compared to the Von Frey filament test right before treatment application. If a pain score of 0 (zero) is recorded the application then proceed with the diagnostic procedure or surgery along with safety monitoring for at least 90 minutes post removal of pledgets, and, the subject will be followed for safety for at least seven days post solution application. The total number of pledgets used, and the amount of Cocaine HCl 10% topical solution used (1 mL per pledget) will be recorded.

Drug: Cocaine HCl 10% Topical Solution

Placebo Topical Solution

PLACEBO COMPARATOR

Placebo Topical Solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.88, about 60 grams of force) to determine and record whether the subject has a pain score of 0 (zero) (0 = No Pain, 10 = Unbearable pain) after treatment application compared to the Von Frey filament test right before treatment application. The subject will then exit the treatment portion of the trial and be followed for safety for seven days . The total number of pledgets used, and the amount of placebo solution used (1 mL per pledget) will be recorded. After a minimum of 90 minutes from the time of study drug pledget removal, the subjects may have their surgery or diagnostic procedure, and the treatment reverts to standard anesthetic management (e.g. application of lidocaine, tetracaine, bupivicaine or other suitable products at the discretion of the investigator).

Drug: Placebo Topical Solution

Interventions

Cocaine HCl 4% Topical Solution DRUG

Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.

Cocaine HCI 4% Topical Solution

Cocaine HCl 10% Topical Solution DRUG

Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.

Cocaine HCI 10% Topical Solution

Placebo Topical Solution DRUG

Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.

Placebo Topical Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjects must meet all of the following criteria prior to enrollment in the study:
• 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 diagnostic procedure or surgery on or through the nasal mucous membranes of either one or two nostrils that merits the use of anesthesia.
• Ability to feel pain sensation normally in the nasal mucous membranes, as verified via Von Frey 5.88 monofilament testing
• Ability to clearly communicate pain and sensation of the nasal mucous membranes.

You may not qualify if:

• 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 male partners of WOCBP who are not willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Contraceptive practices must extend for women at least 30 days and for male partners of WOCBP at least 90 days after the last dose of investigational product in such a manner that the risk of pregnancy or risk to a 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 includes NSAIDs, 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, but only if the subject has not received any study drug during this study.
• Has a history of myocardial infarction, coronary artery disease, congestive heart failure, irregular heart rhythm (as fully defined in sections 7.9.4, 7.9.5 and 7.9.6) or uncontrolled hypertension or is taking monoamine oxidase inhibitors (6). 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 (43)(44).
• 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 delayed recovery with certain anesthetics (e.g. succinylcholine and ester-based anesthetics). (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.
• Has screening 12-lead ECG findings of any abnormalities as listed in section 7.9.4, 7.9.5, and 7.9.6. Generally, these are current or prior myocardial ischemia or infarction, dysrhythmia, or risk of serious dysrhythmia (such as prolonged QT interval) and include any other clinically significant abnormal ECG finding that, in the opinion of the Investigator in consultation with the Medical Monitor, may potentially result in this trial being unsafe for the subject.
• An exception to this would be 7.9.5.11 (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. (36)

Sponsors & Collaborators

• Lannett Company, Inc.: lead

Study Sites (1)

Richmond ENT

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Interventions

Cocaine; Solutions

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Pharmaceutical Preparations

Results Point of Contact

• Title: Lori Christman, PhD
• Organization: STATKING Clinical Services

lori@statkingclinical.com

513-858-2989

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 17, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 16, 2017
• Results First Posted: May 16, 2017

Record last verified: 2017-04

Locations

US (1)