DiagnosticPhase 3NCT01746940
Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia
A Phase 3 study testing Cocaine HCl 4% Topical Solution and Cocaine HCl 10% Topical Solution in people with Diagnostic and Procedures and Surgeries on or Through Accessible Mucous Membranes, run by Lannett Company, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic, Procedures and Surgeries on or Through Accessible 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
- 159 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Jul 2015
- 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
- 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.
Who cannot join
- Has a known allergy to any ester based anesthetics including cocaine HCl, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine, and/or any other compounds of the drugs and/or devices that are part of this protocol. (Amide based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine, Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prilocaine, 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 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
Show all 26Show fewer
- 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.
- Has screening 12-lead ECG findings of any abnormalities as listed in sections 7.9.4, 7.9.5, and 7.9.6 of the protocol. Generally, these are current or prior myocardial ischemia or infarction, dysrhythmia, or risk of serious dysrhythmia (such as prolonged QT interval) An exception to this would be from 7.9.5.11 if sinus bradycardia or sinus tachycardia is present, the Investigator must determine whether this finding is clinically relevant and exclusionary.
- 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 >4.5 mEq/L
- Serum ALT, AST, and bilirubin not exceeding 2X ULN for the lab's reference values
- Cardiac enzymes outside of 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)
- A one-time retest is permitted for any blood test if the original sample was hemolyzed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Connecticut Sinus Center, PC
Bridgeport, Connecticut, 06606
Research Across America
Plano, Texas, 75093
About this study
Official title: A Phase III Investigation of 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.
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.
Read the detailed description
Randomized, prospective, multisite, double-blind, placebo-controlled, parallel-group study of a Placebo Topical Solution versus Cocaine HCl 4% or 10% Topical Solution as an anesthetic prior to a diagnostic procedure or surgery.
In the Safety and Efficacy first phase, subjects will be randomized in a 1:1:1 fashion to one of the three treatment groups (placebo, Cocaine HCl 4% or 10% topical solution) pre-procedure and given one application of up to 4 mL from one bottle of the assigned test product. After pre-procedure Von Frey filament testing, the blind will be broken, but only relative to placebo versus cocaine, not relative to the strength of the cocaine. The placebo subjects will then exit participation in the efficacy portion of the trial, and be followed for safety for 7 days. Treatment group subjects who do not feel pain after Von Frey testing will receive their surgery or diagnostic procedure and also be followed for safety for 7 days.
In the Safety second phase, subjects will be randomized in a 1:1 fashion to one of the two treatment groups (Cocaine HCl 4% or 10% topical solution) pre-procedure and given one application of up to one 4 mL of the assigned test product. After pre-procedure Von Frey filament testing reveals a pain score of 0, subjects will receive their surgery or diagnostic procedure, and then all subjects will be followed for safety for 7 days.
- Conditions
- Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes, of the Nasal Cavities
- Being tested
- Cocaine HCl 4% Topical Solution, Cocaine HCl 10% Topical Solution, Placebo Topical Solution
- Keywords
- Surgery, Surgeries, Nasal, Cavities, Diagnosis, Diagnostic, Nose, Rhinoplasty, Endoscopy, Bronchoscopy
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocaine HCl 4% Topical SolutionDrug
Cocaine HCl 4% Topical Solution
Cocaine HCl 10% Topical SolutionDrug
Cocaine HCl 10% Topical Solution
Placebo Topical SolutionDrug
Placebo Topical Solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Cocaine HCl 10% Topical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to and During a one-day Surgery or Diagnostic Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startMar 2014
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Trial operational issues.
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 DiagnosticStudies 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
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lannett Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746940
- Sponsor's protocol ID
- Protocol COCA4vs10-001
- Status last verified
- Apr 2017
- First submitted
- 23 Jan 2012
- Last updated
- 12 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 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Investigation of 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.
- ClinicalTrials.gov ID
- NCT01746940
- Acronym / sponsor ID
- Protocol COCA4vs10-001
- Conditions
- Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes, of the Nasal Cavities
- Keywords
- Surgery, Surgeries, Nasal, Cavities, Diagnosis, Diagnostic, Nose, Rhinoplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial operational issues.
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Lannett Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Dec 2012 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Randomized, prospective, multisite, double-blind, placebo-controlled, parallel-group study of a Placebo Topical Solution versus Cocaine HCl 4% or 10% Topical Solution as an anesthetic prior to a diagnostic procedure or surgery.
In the Safety and Efficacy first phase, subjects will be randomized in a 1:1:1 fashion to one of the three treatment groups (placebo, Cocaine HCl 4% or 10% topical solution) pre-procedure and given one application of up to 4 mL from one bottle of the assigned test product. After pre-procedure Von Frey filament testing, the blind will be broken, but only relative to placebo versus cocaine, not relative to the strength of the cocaine. The placebo subjects will then exit participation in the efficacy portion of the trial, and be followed for safety for 7 days. Treatment group subjects who do not feel pain after Von Frey testing will receive their surgery or diagnostic procedure and also be followed for safety for 7 days.
In the Safety second phase, subjects will be randomized in a 1:1 fashion to one of the two treatment groups (Cocaine HCl 4% or 10% topical solution) pre-procedure and given one application of up to one 4 mL of the assigned test product. After pre-procedure Von Frey filament testing reveals a pain score of 0, subjects will receive their surgery or diagnostic procedure, and then all subjects will be followed for safety for 7 days.
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 |
|---|---|---|
| Group 1, Placebo Topical Solution | Placebo comparator | Drug: Placebo Topical SolutionGroup 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. |
| Group 2, Cocaine HCl 4% Topical Solution | Active comparator | Drug: Cocaine HCl 4% Topical SolutionGroup 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. |
| Group 3, Cocaine HCl 10% Topical Solution | Active comparator | Drug: Cocaine HCl 10% Topical SolutionGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- Has a known allergy to any ester based anesthetics including cocaine HCl, procaine, tetracaine, chloroprocaine, dibucaine, or benzocaine, and/or any other compounds of the drugs and/or devices that are part of this protocol. (Amide based anesthetic allergies are NOT exclusionary. Amide based anesthetics are: Lidocaine, Mepivicaine, Bupivicaine, Levobupivicaine, Ropivicaine, Etidocaine, Prilocaine, 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 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.
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 SolutionCocaine HCl 4% Topical Solution | Drug | Group 2, Cocaine HCl 4% Topical Solution |
| Cocaine HCl 10% Topical SolutionCocaine HCl 10% Topical Solution | Drug | Group 3, Cocaine HCl 10% Topical Solution |
| Placebo Topical SolutionPlacebo Topical Solution | Drug | Group 1, Placebo Topical Solution |
Primary outcome
Immediate and Sustained Analgesic Success
Time frame: Prior to and During a one-day Surgery or Diagnostic Procedure
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cocaine HCl 4% Topical Solution and Cocaine HCl 10% Topical Solution in people with Diagnostic and Procedures and Surgeries on or Through Accessible Mucous Membranes, run by Lannett Company, Inc. at 2 sites in United States.
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 5 inclusion and 26 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: stopped early, as of the sponsor's last update on 12 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 2 sites 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 11 Jul 2016). 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 Analgesic Success (time frame: Prior to and During a one-day Surgery or Diagnostic Procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.