Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia

NCT01746940 | Terminated Phase 3 Results

• 1 other identifier: Protocol COCA4vs10-001
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diagnostic; Procedures and Surgeries on or Through Accessible Mucous Membranes; of the Nasal Cavities

Keywords

Surgery; Surgeries; Nasal; Cavities; Diagnosis; Diagnostic; Nose; Rhinoplasty; Endoscopy; Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• Immediate and Sustained Analgesic Success

  The primary endpoint for this trial is analgesic success immediately after application of study drug and sustained throughout the diagnostic procedure or surgery for each nostril that received the study drug application. 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 application of the assigned treatment solution (placebo, 4% or 10% Cocaine HCl). During the procedure or surgery, no further analgesic treatment is required (only 4% and 10% Cocaine HCl subjects who receive a procedure or surgery). Otherwise, the subject will be considered a treatment failure. Subjects with missing primary outcome data are marked as treatment failures in all treatment groups.

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

Study Arms (3)

Group 1, Placebo Topical Solution

PLACEBO COMPARATOR

Group 1: Placebo group -Placebo solution, up to 4 mL, is applied for 20 minutes via cotton pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.18, about 15 grams of force) to determine and record pain on a pain scale of 0 to 10. The subject will then exit the treatment portion of the trial and be followed for safety for seven days . All placebo subjects, regardless of Von Frey filament test results, will undergo Phase 1 recovery (i.e. at least 90 minutes after cotton pledget removal) and associated required study procedures (including the final 12 lead ECG). After a minimum of 24 hours from the time of study drug pledget removal, the subject may continue the procedure, and the treatment reverts to standard anesthetic management (suitable products at the discretion of the investigator). Alternatively, at the investigator's discretion, the diagnostic procedure or surgery may be delayed until study termination.

Drug: Placebo Topical Solution

Group 2, Cocaine HCl 4% Topical Solution

ACTIVE COMPARATOR

Group 2: Cocaine HCI 4% Group - Cocaine HCl 4% topical solution, up to 4 mL, is applied for 20 minutes via cotton pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.18, about 15 grams of force) to determine and record pain on a pain scale of 0 to 10. If a score of 0 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 amount of Cocaine HCl 4% topical solution used will be recorded.

Drug: Cocaine HCl 4% Topical Solution

Group 3, Cocaine HCl 10% Topical Solution

ACTIVE COMPARATOR

Group 3: Cocaine HCI 10% Group - Cocaine HCl 10% topical solution, up to 4 mL, is applied for 20 minutes via cotton pledget(s), then the nasal site is tested with a Von Frey (or equivalent) filament (Size 5.18, about 15 grams of force) to determine and record pain on a pain scale of 0 to 10. If a score of 0 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 amount of Cocaine HCl 10% topical solution used will be recorded.

Drug: Cocaine HCl 10% Topical Solution

Interventions

Cocaine HCl 4% Topical Solution DRUG

Cocaine HCl 4% Topical Solution

Group 2, Cocaine HCl 4% Topical Solution

Cocaine HCl 10% Topical Solution DRUG

Cocaine HCl 10% Topical Solution

Group 3, Cocaine HCl 10% Topical Solution

Placebo Topical Solution DRUG

Placebo Topical Solution

Group 1, 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:

• 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.

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 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.
• Hemoglobin \<8.5 g/dL; a one-time retest will be allowed for Hb 8.3-8.4 g/dL

Sponsors & Collaborators

• Lannett Company, Inc.: lead

Study Sites (2)

The Connecticut Sinus Center, PC

Bridgeport, Connecticut, 06606, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Disease

Interventions

Cocaine; Solutions

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: January 23, 2012
• First Posted: December 11, 2012
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 12, 2017
• Results First Posted: July 11, 2016

Record last verified: 2017-04

Locations

US (2)