Trial Outcomes & Findings for Topical Application of Cocaine HCl 4%, or 10%, or Placebo Solution in Local (Topical) Anesthesia (NCT NCT02500836)

Last Updated: 2017-05-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

646 participants

Primary outcome timeframe

One Day, Single office based diagnostic procedure or surgery

Results posted on

2017-05-16

Participant Flow

Subjects were recruited from patients scheduled for an office-based or operating room-based diagnostic procedure or surgery on or through accessible mucous membranes of the nasal cavities.

A screening visit was conducted to ensure that each subject met inclusion/exclusion criteria for the study. Subjects who met all eligibility criteria were then enrolled for the drug application and procedure visit, which may have been on the same day as the screening visit.

Participant milestones

Participant milestones
Measure	Cocaine HCI 4% Topical Solution Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCI 10% Topical Solution Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution Subjects randomized to receive Placebo Topical Solution
Overall Study STARTED	259	259	128
Overall Study COMPLETED	256	254	127
Overall Study NOT COMPLETED	3	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cocaine HCI 4% Topical Solution n=259 Participants Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCI 10% Topical Solution n=259 Participants Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution n=128 Participants Subjects randomized to receive Placebo Topical Solution	Total n=646 Participants Total of all reporting groups
Age, Continuous	38.42 years STANDARD_DEVIATION 13.34 • n=99 Participants	37.50 years STANDARD_DEVIATION 12.76 • n=107 Participants	36.01 years STANDARD_DEVIATION 12.34 • n=206 Participants	37.57 years STANDARD_DEVIATION 12.92 • n=7 Participants
Sex: Female, Male Female	169 Participants n=99 Participants	156 Participants n=107 Participants	68 Participants n=206 Participants	393 Participants n=7 Participants
Sex: Female, Male Male	90 Participants n=99 Participants	103 Participants n=107 Participants	60 Participants n=206 Participants	253 Participants n=7 Participants
Region of Enrollment United States	259 participants n=99 Participants	259 participants n=107 Participants	128 participants n=206 Participants	646 participants n=7 Participants

PRIMARY outcome

Timeframe: One Day, Single office based diagnostic procedure or surgery

Population: The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug.

Outcome measures

Outcome measures
Measure	Cocaine HCI 4% Topical Solution n=258 Participants Subjects randomized to receive Cocaine HCl 4% Topical Solution	Placebo Topical Solution n=127 Participants Subjects randomized to receive Placebo Topical Solution
Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution	0.7093 proportion of participants Interval 0.6498 to 0.764	0.1969 proportion of participants Interval 0.1316 to 0.2767

SECONDARY outcome

Timeframe: One Day, Single office based diagnostic procedure or surgery

Population: The analysis of secondary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug. The analysis of this secondary efficacy endpoint includes comparisons to the primary endpoint for the Placebo Topical Solution treatment group.

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 10% 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 10% Cocaine HCl subjects who receive a diagnostic procedure or surgery).

Outcome measures

Outcome measures
Measure	Cocaine HCI 4% Topical Solution n=254 Participants Subjects randomized to receive Cocaine HCl 4% Topical Solution	Placebo Topical Solution n=127 Participants Subjects randomized to receive Placebo Topical Solution
Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution	0.8268 proportion of participants Interval 0.7745 to 0.8712	0.1969 proportion of participants Interval 0.1316 to 0.2767

Adverse Events

Cocaine HCI 4% Topical Solution

Serious events: 0 serious events

Other events: 218 other events

Deaths: 0 deaths

Cocaine HCI 10% Topical Solution

Serious events: 0 serious events

Other events: 237 other events

Deaths: 0 deaths

Placebo Topical Solution

Serious events: 0 serious events

Other events: 94 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Lori Christman, PhD

STATKING Clinical Services

Phone: 513-858-2989

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor right of review of publication, right to remove confidential or proprietary information, and all multi-center data publication done before any additional publications.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cocaine HCI 4% Topical Solution n=259 participants at risk Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCI 10% Topical Solution n=259 participants at risk Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution n=128 participants at risk Subjects randomized to receive Placebo Topical Solution
Cardiac disorders Atrioventricular Block First Degree	0.39% 1/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.77% 2/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	2.3% 3/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Cardiac disorders Bradycardia	3.1% 8/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.39% 1/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	3.9% 5/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Cardiac disorders Sinus Tachycardia	2.3% 6/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	3.5% 9/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Cardiac disorders Tachycardia	4.6% 12/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	10.8% 28/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.78% 1/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Cardiac disorders Tachycardia Paroxysmal	0.77% 2/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	2.3% 6/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.78% 1/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Gastrointestinal disorders Nausea	1.2% 3/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	1.2% 3/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Investigations Electrocardiogram QRS Complex Prolonged	1.5% 4/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	3.1% 8/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	2.3% 3/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Investigations Electrocardiogram QT Prolonged	2.7% 7/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	3.9% 10/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	2.3% 3/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Investigations Heart Rate Increased	0.77% 2/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	2.7% 7/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.78% 1/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Musculoskeletal and connective tissue disorders Exostosis	0.39% 1/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	3.1% 8/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Nervous system disorders Dizziness	0.77% 2/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	1.2% 3/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Musculoskeletal and connective tissue disorders Headache	1.5% 4/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.77% 2/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Psychiatric disorders Anxiety	1.5% 4/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Respiratory, thoracic and mediastinal disorders Nasal Septum Deviation	4.2% 11/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	6.2% 16/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	1.6% 2/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Respiratory, thoracic and mediastinal disorders Nasal Turbinate Hypertrophy	1.2% 3/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.39% 1/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	2.3% 3/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Vascular disorders Diastolic Hypertension	0.77% 2/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	1.5% 4/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.78% 1/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Vascular disorders Hypertension	77.6% 201/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	84.9% 220/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	66.4% 85/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.
Vascular disorders Hypotension	0.39% 1/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	0.00% 0/259 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.	1.6% 2/128 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.