Trial Outcomes & Findings for Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia (NCT NCT01746940)

NCT ID: NCT01746940

Last Updated: 2017-05-12

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 159 participants
• Primary outcome timeframe: Prior to and During a one-day Surgery or Diagnostic Procedure
• Results posted on: 2017-05-12

Participant Flow

Subjects were recruited from patients scheduled for an office-based or operating room-based 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 on the drug application and procedure visit, which may have taken place on the same day as the screening visit.

Participant milestones

Measure	Cocaine HCl 4% Topical Solution Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCl 10% Topical Solution Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution Subjects randomized to receive Placebo Topical Solution	Not Randomized Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
Safety and Efficacy First Phase STARTED	39	41	40	3
Safety and Efficacy First Phase COMPLETED	39	41	40	0
Safety and Efficacy First Phase NOT COMPLETED	0	0	0	3
Safety Second Phase STARTED	18	18	0	0
Safety Second Phase COMPLETED	18	18	0	0
Safety Second Phase NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cocaine HCl 4% Topical Solution n=57 Participants Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCl 10% Topical Solution n=59 Participants Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution n=40 Participants Subjects randomized to receive Placebo Topical Solution	Not Randomized n=3 Participants Enrolled subjects who are not randomized to treatment due to early withdrawal from the study	Total n=159 Participants Total of all reporting groups
Age, Continuous	39.26 years STANDARD_DEVIATION 12.55 • n=5 Participants	40.98 years STANDARD_DEVIATION 12.45 • n=7 Participants	34.58 years STANDARD_DEVIATION 13.82 • n=5 Participants	51.67 years STANDARD_DEVIATION 16.17 • n=4 Participants	38.96 years STANDARD_DEVIATION 13.14 • n=21 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	37 Participants n=7 Participants	23 Participants n=5 Participants	1 Participants n=4 Participants	91 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	17 Participants n=5 Participants	2 Participants n=4 Participants	68 Participants n=21 Participants

PRIMARY outcome

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

Population: The analysis of primary outcome data is based on an intent-to-treat population, which includes all randomized subjects who received study drug and who are enrolled in the safety and efficacy phase of the study.

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.

Outcome measures

Measure	Cocaine HCl 4% Topical Solution n=39 Participants Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCl 10% Topical Solution n=41 Participants Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution n=40 Participants Subjects randomized to receive Placebo Topical Solution
Immediate and Sustained Analgesic Success	0.5385 proportion of particpants analyzed Interval 0.3718 to 0.6991	0.7561 proportion of particpants analyzed Interval 0.597 to 0.8764	0.3750 proportion of particpants analyzed Interval 0.2273 to 0.542

Adverse Events

Cocaine HCl 4% Topical Solution

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Cocaine HCl 10% Topical Solution

Serious events: 1 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo Topical Solution

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cocaine HCl 4% Topical Solution n=57 participants at risk Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCl 10% Topical Solution n=59 participants at risk Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution n=40 participants at risk Subjects randomized to receive Placebo Topical Solution
Cardiac disorders Myocardial ischaemia	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Number of events 1 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.

Other adverse events

Measure	Cocaine HCl 4% Topical Solution n=57 participants at risk Subjects randomized to receive Cocaine HCl 4% Topical Solution	Cocaine HCl 10% Topical Solution n=59 participants at risk Subjects randomized to receive Cocaine HCl 10% Topical Solution	Placebo Topical Solution n=40 participants at risk Subjects randomized to receive Placebo Topical Solution
Cardiac disorders Bradycardia	3.5% 2/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Cardiac disorders Bundle branch block right	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Cardiac disorders Tachycardia	1.8% 1/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	3.4% 2/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Eye disorders Photopsia	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Eye disorders Vision blurred	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Gastrointestinal disorders Abdominal pain	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Gastrointestinal disorders Dry mouth	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Investigations Blood pressure increased	1.8% 1/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Investigations Electrocardiogram abnormal	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Investigations Heart rate decreased	5.3% 3/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	13.6% 8/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	12.5% 5/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Investigations Heart rate increased	28.1% 16/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	23.7% 14/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	17.5% 7/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Metabolism and nutrition disorders Tetany	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Nervous system disorders Syncope	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Psychiatric disorders Anxiety	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Hyperventilation	3.5% 2/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	5.0% 2/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Intranasal paraesthesia	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Nasal polyps	1.8% 1/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	3.4% 2/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	2.5% 1/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	0.00% 0/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Vascular disorders Diastolic hypertension	7.0% 4/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	3.4% 2/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	5.0% 2/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Vascular disorders Hypertension	82.5% 47/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	88.1% 52/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	70.0% 28/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.
Vascular disorders Hypotension	7.0% 4/57 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	1.7% 1/59 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.	7.5% 3/40 • Adverse events were monitored for each subject from the time informed consent was signed until termination from the study, up through the seven day follow up visit. Serious classification based on the FDA regulatory definition of a serious AE.

Additional Information

Lori Christman, PhD

STATKING Clinical Services

Phone: 513-858-2989

Email: lori@statkingclinical.com

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