Any Ear Nose or Throat ConditionsPhase 3NCT02500836

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

A Phase 3 study testing Cocaine HCl 4% Topical Solution and Cocaine HCl 10% Topical Solution in people with Any Ear Nose or Throat Conditions and With Identified Need for a Diagnostic Procedure or Surgery on or Through the Mucous Membranes of the Nasal Cavities, run by Lannett Company, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: 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
What is being tested?: Cocaine HCl 4% Topical Solution and Cocaine HCl 10% Topical Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 646 participants
Where: 1 siteUnited States
Study dates: Sep 2015to Jul 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

Has a known allergy to any ester based anesthetics including cocaine, procaine, tetracaine, chlorprocaine, dibucaine, or benzocaine and/or any other compounds of the drugs and/or devices that are part of this protocol. (Amide based or other non-ester based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine, Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prolicaine, and Articaine).
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

Show all 28Show fewer

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.
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 except coffee, tea, or herbal tea 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. Coffee, Tea, and Herbal Tea are not exclusionary criteria or prohibited medications as they are food products not prescription or nonprescription products.
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)
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/mcL; a one-time retest will be allowed for WBC 3.3-3.4 x 103 cells/mcL
Platelets < 100 x 103 platelets/mcL; a one-time retest will be allowed for platelets 90-99x 103 platelets/mcL
Serum Potassium <3.5 or >5.0 mEq/L
Serum ALT, AST, and bilirubin exceeding 2X ULN for the lab's reference values
Cardiac enzymes above 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)
Subjects is a member of the Investigational Team, including Investigators or Sub-Investigators, or their immediate family.
A one-time retest is permitted for any blood test if the original sample was hemolyzed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Richmond ENT
Richmond, Virginia, 23235

Other trials in United States

About this study

Official title: Phase III Topical Application of Cocaine HCl 4% Solution on Safety/Efficacy & Cocaine HCl 4% & 10% Solution on Safety in Local Anesthesia for Diagnostic Procedures & Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities

Read the detailed description

Eligible subjects will undergo either an office-based or operating room-based procedure or surgery. The approximately 620 subjects will be randomized in a 2:2:1 fashion to one of the three treatment groups (248 subjects randomized to the Cocaine HCl 4% solution, 248 subjects randomized to the Cocaine HCl 10%, and 124 subjects randomized to the placebo solution) pre-procedure and given one application of the assigned test product with Von Frey filament testing occurring after application.

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
Being tested: Cocaine HCl 4% Topical Solution, Cocaine HCl 10% Topical Solution, Placebo Topical Solution
Keywords: Ear, Nose, Throat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cocaine HCl 4% Topical SolutionDrug
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 HCl 10% Topical SolutionDrug
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 SolutionDrug
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.

Study groups in NCT02500836
Study group	Role	What they receive
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. Receives: 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. Receives: 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). Receives: Drug: Placebo Topical Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: One Day, Single office based diagnostic procedure or surgery

Secondary outcomes (1)

Immediate and Sustained Anesthetic Success for Cocaine HCl 10% 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 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).
Measured: One Day, Single office based diagnostic procedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2015Jul 2016

First posted17 Jul 2015 (estimated)
Study startSep 2015
Primary completionJul 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Any Ear Nose or Throat ConditionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 646 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02500836
Sponsor's protocol ID: COCA4vs10-002
Status last verified: Apr 2017
First submitted: 12 Jul 2015
Last updated: 16 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase III Topical Application of Cocaine HCl 4% Solution on Safety/Efficacy & Cocaine HCl 4% & 10% Solution on Safety in Local Anesthesia for Diagnostic Procedures & Surgeries on or Through Accessible Mucous Membranes of the Nasal Cavities
ClinicalTrials.gov ID: NCT02500836
Acronym / sponsor ID: COCA4vs10-002
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 646 participants (actual)
Lead sponsor: Lannett Company, Inc.Industry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 17 Jul 2015 (estimated)
Results: Posted 16 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cocaine HCI 4% Topical Solution	Experimental	Drug: Cocaine HCl 4% Topical SolutionCocaine 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.
Cocaine HCI 10% Topical Solution	Experimental	Drug: Cocaine HCl 10% Topical SolutionCocaine 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.
Placebo Topical Solution	Placebo comparator	Drug: Placebo Topical SolutionPlacebo 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (28 listed)

Has a known allergy to any ester based anesthetics including cocaine, procaine, tetracaine, chlorprocaine, dibucaine, or benzocaine and/or any other compounds of the drugs and/or devices that are part of this protocol. (Amide based or other non-ester based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine, Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prolicaine, and Articaine).
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cocaine HCl 4% Topical SolutionTopical 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.	Drug	Cocaine HCI 4% Topical Solution
Cocaine HCl 10% Topical SolutionTopical 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.	Drug	Cocaine HCI 10% Topical Solution
Placebo Topical SolutionTopical 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.	Drug	Placebo Topical Solution

Primary outcome

Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution
Time frame: One Day, Single office based diagnostic procedure or surgery
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.

1 secondary outcome

Immediate and Sustained Anesthetic Success for Cocaine HCl 10% Topical Solution
Time frame: One Day, Single office based diagnostic procedure or surgery

Results and safety

Results posted to the registry on 16 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cocaine HCI 4% Topical Solution	259	256
Cocaine HCI 10% Topical Solution	259	254
Placebo Topical Solution	128	127

Primary outcome: Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution

Time frame: One Day, Single office based diagnostic procedure or surgery. Number (95% Confidence Interval). Unit: proportion of participants

Measure	Cocaine HCI 4% Topical Solution n = 258	Placebo Topical Solution n = 127
Value	0.7093 (0.6498 to 0.7640)	0.1969 (0.1316 to 0.2767)

Cocaine HCI 4% Topical Solution vs Placebo Topical Solution: p <0.0001, Fisher Exact

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

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored for each subject from the time informed consent was signed until termination from the study.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cocaine HCI 4% Topical Solution	0 of 259 (0%)	218 of 259 (84.2%)	Not reported
Cocaine HCI 10% Topical Solution	0 of 259 (0%)	237 of 259 (91.5%)	Not reported
Placebo Topical Solution	0 of 128 (0%)	94 of 128 (73.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate and Sustained Anesthetic Success for Cocaine HCl 4% Topical Solution and Placebo Topical Solution (time frame: One Day, Single office based diagnostic procedure or surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02500836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017.