A Phase 3 interventional study of Benzocaine 8 mg and Placebo in Sore Throat, sponsored by McNeil AB. Completed at 19 sites in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-18.
Sponsored by McNeil AB (formerly part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
A multi-center, double-blind, randomized, parallel-group, placebo-controlled study to determine the efficacy and safety of a benzocaine lozenge for symptomatic treatment of sore throat caused by acute upper respiratory tract infection in adults.
This multi-center, double-blind, randomized, parallel-group, placebo-controlled study consists of two parts, an initial efficacy and safety part performed at the clinic on the first treatment day and a safety follow up home-use treatment part with an intermediate site visit.
Following screening and randomization, subjects suffering from throat pain caused by an acute upper respiratory tract infection will receive a single dose of study medication, benzocaine 8 mg or placebo lozenge, and will be followed for a 3 hour assessment period where primary and secondary efficacy measurements will be collected.
Onset and duration of what the subject consider to be perceptible and meaningful pain relief, respectively, will be measured by collecting time point for reported onset in relation to time of intake of the single dose.
The subjects will assess their pain intensity and the degree of difficulty swallowing during multiple assessment time points throughout the 3 hour period on 11-point numerical rating scales (NRS) where 0=no pain/not difficult, 10=very severe pain/very difficult.
The subjects will rate their sore throat condition in a subject questionnaire at baseline and after 2 and approximately 72 hours of treatment. The subjects will also rate how satisfied they were with the assigned study medication as a treatment for sore throat in a global evaluation assessment at the end of the 3 hour assessment period and after approximately 72 hours of treatment.
After initiation of treatment and the initial efficacy part of the study (Day 1), the subjects will be released for home based treatment according to label to complete the safety part of the study. The subjects will be equipped with study medication according to randomization and diaries to record number of study medication doses taken per day. The subjects will be instructed to follow their respective treatment label and return to the site for safety follow up at study Day 4 (target approximately 72 hours of treatment) and at the end of treatment, at Day 6 (target approximately 120 hours of treatment).
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 260 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →McNeil AB is the lead sponsor of 42 studies on the registry; 1 is open to participants now.
First submitted before McNeil AB left Johnson & Johnson.
Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Subject Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
Subject Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Benzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Drug: Benzocaine 8 mg
Placebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Drug: Placebo
Benzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Also known as: Benzocaine lozenge
Placebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
Also known as: Placebo lozenge
Time to meaningful pain relief.
A timer is started upon the intake of a single dose and stopped when the subject considers he/she has experienced meaningful pain relief.
Time frame: 3 hours
Time to perceptible pain relief (onset of therapeutic effect).
A timer is started upon the intake of a single dose and stopped when the subject considers he/she has experienced perceptible pain relief.
Time frame: 3 hours
Change from baseline in sore throat pain intensity self-ratings at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Change from baseline in sore throat pain intensity self-ratings at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Time frame: 15 minutes
Mean change from baseline in sore throat pain intensity self-ratings based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Mean change from baseline in sore throat pain intensity self-ratings based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Time frame: 3 hours
Change from baseline in self-ratings of difficulty swallowing at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Change from baseline in self-ratings of difficulty swallowing at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.
Time frame: 15 minutes
Mean change from baseline in self-ratings of difficulty swallowing based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Mean change from baseline in self-ratings of difficulty swallowing based on all assessments up to 15, 30, 60, 120, and 180 min after intake as well as during the second (60+ to 120 min) and third hour (120+ to 180 min) after intake, respectively.
Time frame: 3 hours
Continuous period of time within the 3 hour test period with perceptible pain relief.
Continuous period of time within the 3 hour test period with perceptible pain relief.
Time frame: 3 hours
Continuous period of time within the 3 hour test period with meaningful pain relief.
Continuous period of time within the 3 hour test period with meaningful pain relief.
Time frame: 3 hours
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition diverts the subject's concentration, assessed after 2 and 72 hour of treatment, respectively.
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition diverts the subject's concentration, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition makes it difficult for the subject to speak, assessed after 2 and 72 hour of treatment, respectively.
Change from baseline in self-ratings, referring to the time period since start of treatment, of the extent to which the sore throat condition makes it difficult for the subject to speak, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Subject ratings with respect to the degree of experienced improvement in their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Subject ratings with respect to the degree of experienced improvement in their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Subject ratings with respect to the extent to which they were able to forget their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Subject ratings with respect to the extent to which they were able to forget their sore throat condition, assessed after 2 and 72 hour of treatment, respectively.
Time frame: 72 hours
Subject ratings with respect to the degree of overall satisfaction with their assigned study medication for sore throat, rated at the end of the 3 hour assessment period and 72 hours of treatment, respectively.
Subject ratings with respect to the degree of overall satisfaction with their assigned study medication for sore throat, rated at the end of the 3 hour assessment period and 72 hours of treatment, respectively.
Time frame: 72 hours
Frequency and severity of treatment emergent AEs reported during the study
Frequency and severity of treatment emergent AEs reported during the study
Time frame: Through study completion, an average of 5 months.
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment
Frequency and severity of AEs possibly, probably, or very likely related to the study drug during study treatment
Time frame: Through study completion, an average of 5 months
Occurrence of serious AEs (SAEs), and AEs resulting in pre-mature withdrawal from the study
Occurrence of serious AEs (SAEs), and AEs resulting in pre-mature withdrawal from the study
Time frame: Through study completion, an average of 5 months.
Subject compliance with the study medication dosing regimen by reporting of doses taken in subject diary.
Subject compliance with the study medication dosing regimen by reporting of doses taken in subject diary.
Time frame: Through study completion, an average of 5 months.
Ran from Feb 2018 to primary completion in Apr 2018, 2 months.
Of 13 phase 3 interventional studies under Pharyngitis, half reached primary completion within 3 months of starting (the median); a quarter within 2 and three quarters within 6. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Benzocaine