A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat.

NCT03432923 | Completed Phase 3

• 2 other identifiers: CO-161004120104-URCT129649CGH3001
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

• 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.

  3 hours

Secondary Outcomes (15)

• Time to perceptible pain relief (onset of therapeutic effect).

  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.

  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.

  3 hours

• Change from baseline in self-ratings of difficulty swallowing at 2.5, 5, 7.5, 10 and 15 min after intake, respectively.

  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.

  3 hours

Other Outcomes (1)

• Subject compliance with the study medication dosing regimen by reporting of doses taken in subject diary.

  Through study completion, an average of 5 months.

Study Arms (2)

Benzocaine 8 mg

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Benzocaine 8 mg DRUG

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

Benzocaine 8 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of 18 years of age or older, suffering from throat pain caused by acute upper respiratory tract infection;
• Symptoms of acute throat pain have been persisting for minimum of 3 hour and maximum 72 hours;
• Have body mass index (BMI) 18.5 to 35 (inclusive) at screening;
• Indicate at least a score of 5 on an 11-point (0-10) pain intensity numerical rating scale (PI-NRS) at screening and at baseline;
• Females of childbearing potential must have a negative urine pregnancy test at screening;
• Male and non-pregnant, non-lactating female agree to the contraceptive requirements (including female partner´s use of highly effective form of birth control for at least 3 months before the study, during the study and up to 30 days after the last dose of investigational product) as outlined in protocol.
• Are able and willing to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel´s assessment;
• Are able to read and understand the local language;
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Are female and who are pregnant, breastfeeding or intended pregnancy;
• Are male with a pregnant partner or a partner who is currently trying to become pregnant;
• Have a known allergy or hypersensitivity to benzocaine or any of the excipients of the formulations;
• Known or suspected NADH-diaphorase deficiency;
• Presence or history of medical condition in the investigator's opinion that may jeopardize the subject's safety or well-being, or the integrity of the study (e.g., hepatic, renal, pancreatic, gastrointestinal, cardiovascular, cerebrovascular, thyroid, seizure, asthma, allergy, drug intolerance, or psychiatric disorders; uncontrolled hypertension indicated as systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg; or uncontrolled diabetes in the last 6 months);
• Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);
• Clinically significant laboratory abnormality that cannot be explained by the acute upper respiratory tract infection. Subjects with increased glucose level after a meal are eligible if there is no uncontrolled diabetes in last 6 months, but not eligible if increased glucose level in a fasted state;
• Presenting axillary temperature of 38.5 Celsius degrees or above;
• Acute and/or chronic respiratory tract disease or other concomitant disease with potential to compromise breathing (asthma, bronchopneumonia, bronchitis);
• Blood dyscrasias or suspected fungal upper respiratory tract infection e.g., candida infection;
• Known or suspected bacterial upper respiratory tract infection or purulent pharyngitis;
• Known or suspected diphtheria or clinical signs of active herpes infection;
• Positive result in express throat test for Streptococcus;
• Known or suspected pneumonia as verified with chest X-ray examination;

Sponsors & Collaborators

• McNeil AB: lead
• Janssen Pharmaceutica N.V., Belgium: collaborator

Study Sites (19)

Railway Clinical Hospital n.a. N.A. Semashko Lyublino railway station of the Russian Railways, Stavropolskaya str., 23, build.1,

Moscow, 109386, Russia

Location

City Clinical Hospital n.a. V.M. Buyanov Bakinskaya str., 26

Moscow, 115516, Russia

Location

Central Clinical Hospital of Russian Academy of Sciences Litovskiy bulvar, 1A

Moscow, 117593, Russia

Location

Federal State Budgetary Institution "Policlinic #5" of Administrative Department of the President of the Russian Federation Plyushchikha str., 14

Moscow, 119121, Russia

Location

Unimed-C 26 Bakinskikh Komissarov str., 11

Moscow, 119571, Russia

Location

Clinic of the Modern Medicine Pobedy ploshad, 2, bldg. 1

Moscow, 121170, Russia

Location

State Budgetary Healthcare Institution City Clinical Hospital n.a. M.E. Zhadkevich

Moscow, 121374, Russia

Location

Hospital of Russian Academy of Sience Oktyabrskiy prospect, 3

Moscow, 142190, Russia

Location

International Medical Centre SOGAZ Malaya Konushennaya str., 8A

Saint Petersburg, 191186, Russia

Location

" City Polyclinic #25 of the Nevsky District of SPB" Prospekt Solidarnosti, 1, bldg 1, litera "А"

Saint Petersburg, 193312, Russia

Location

Clinical Hospital of Russian Academy of Sciences Morisa Toreza str., 72

Saint Petersburg, 194017, Russia

Location

LLC "Medical Center "Reavita Med SPb" Uchebniy per., 2

Saint Petersburg, 194354, Russia

Location

OOO Medpomoshch " Medicaid LLC" Vyborgskoe shosse, 5, bldg. 1

Saint Petersburg, 194356, Russia

Location

Medical Research Institute LLC Koli Tomchaka str., 25

Saint Petersburg, 196084, Russia

Location

Eco-safety Ltd Prospekt Gagarina, 65

Saint Petersburg, 196143, Russia

Location

City Out-Patient Clinic #51 Prospekt Kosmonavtov, 35

Saint Petersburg, 196211, Russia

Location

LLC Kurator Krasnoputilovskaya str., 125

Saint Petersburg, 196240, Russia

Location

BioEq, LLC "Lit. Zh, 23, Krasnogvardejskiy per.

Saint Petersburg, 197342, Russia

Location

St. Petersburg SBHI City Hospital #40, 9 letter B, Borisova str

Saint Petersburg, 197706, Russia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pharyngitis

Interventions

Benzocaine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Steven Sacavage

  Medical Affairs and Clinical Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design. Placebo indistinguishable to active in appearance and dosing schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 14, 2018
• Study Start: February 2, 2018
• Primary Completion: April 21, 2018
• Study Completion: April 21, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

RU (19)