Status:
COMPLETED
A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat.
Lead Sponsor:
McNeil AB
Collaborating Sponsors:
Janssen Pharmaceutica N.V., Belgium
Conditions:
Sore Throat
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Subject Inclusion Criteria
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- 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.
- Subject Exclusion Criteria
- 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;
- Routine use of oral analgesics, and/or NSAIDs ≥5 times per week. If routine use is stopped, a wash out period of at least 24 hours should have been passed since the last dose;
- Treatment with steroids, oro-pharyngeal therapeutic agents, anticonvulsants, psychotropic or immunosuppressant agents within 8 hour (or with prolonged action NSAIDs within 10 days) or antibiotics within 14 days up to first dose;
- Use on any confectionery lozenge/tablet/gum or any products with demulcent properties within previous 2 hour prior to first dose;
- Use of any analgesic, oral anesthetics, antipyretic or "cold" medication within previous 8 hour, for Naproxen containing products within previous 12 hour prior to first dose;
- Use of any antiseptics and/or oral rinses (e.g., Hexetidine, Listerine, Myramistin) within previous 2 hours prior to first dose;
- Participate in any interventional clinical studies within 30 days before screening or had participated in this current study previously;
- Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other site personnel, employees of Sponsor (including group of Johnson \& Johnson companies) subsidiaries, contractors of Sponsor (including group of Johnson \& Johnson companies), and the families of each).
Exclusion
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2018
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03432923
Start Date
February 2 2018
End Date
April 21 2018
Last Update
October 18 2018
Active Locations (19)
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1
Railway Clinical Hospital n.a. N.A. Semashko Lyublino railway station of the Russian Railways, Stavropolskaya str., 23, build.1,
Moscow, Russia, 109386
2
City Clinical Hospital n.a. V.M. Buyanov Bakinskaya str., 26
Moscow, Russia, 115516
3
Central Clinical Hospital of Russian Academy of Sciences Litovskiy bulvar, 1A
Moscow, Russia, 117593
4
Federal State Budgetary Institution "Policlinic #5" of Administrative Department of the President of the Russian Federation Plyushchikha str., 14
Moscow, Russia, 119121