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

• Status: Completed
• Trial end date: 2018-04-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil AB
• Collaborator: Janssen Pharmaceutica N.V., Belgium
• Treatments: Benzocaine

Criteria

Subject Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

1. Subjects of 18 years of age or older, suffering from throat pain caused by acute upper respiratory tract infection;

2. Symptoms of acute throat pain have been persisting for minimum of 3 hour and maximum 72 hours;

3. Have body mass index (BMI) 18.5 to 35 (inclusive) at screening;

4. 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;

5. Females of childbearing potential must have a negative urine pregnancy test at screening;

6. 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.

7. 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;

8. Are able to read and understand the local language;

9. 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:

1. Are female and who are pregnant, breastfeeding or intended pregnancy;

2. Are male with a pregnant partner or a partner who is currently trying to become pregnant;

3. Have a known allergy or hypersensitivity to benzocaine or any of the excipients of the formulations;

4. Known or suspected NADH-diaphorase deficiency;

5. 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);

6. Suspected alcohol or substance abuse (e.g., amphetamines, benzodiazepines, cocaine, marijuana, opiates);

7. 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;

8. Presenting axillary temperature of 38.5 Celsius degrees or above;

9. Acute and/or chronic respiratory tract disease or other concomitant disease with potential to compromise breathing (asthma, bronchopneumonia, bronchitis);

10. Blood dyscrasias or suspected fungal upper respiratory tract infection e.g., candida infection;

11. Known or suspected bacterial upper respiratory tract infection or purulent pharyngitis;

12. Known or suspected diphtheria or clinical signs of active herpes infection;

13. Positive result in express throat test for Streptococcus;

14. Known or suspected pneumonia as verified with chest X-ray examination;

15. 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;

16. 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;

17. Use on any confectionery lozenge/tablet/gum or any products with demulcent properties within previous 2 hour prior to first dose;

18. 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;

19. Use of any antiseptics and/or oral rinses (e.g., Hexetidine, Listerine, Myramistin) within previous 2 hours prior to first dose;

20. Participate in any interventional clinical studies within 30 days before screening or had participated in this current study previously;

21. 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).