Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering from acute viral pharyngitis.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Ambroxol; Benzocaine

Criteria

INCLUSION CRITERIA

1. Patients having a sore throat with acute viral pharyngitis.

2. Female and male patients between the ages of 18 and 80 years.

3. The throat pain intensity is rated at least moderate on the VRS (PI).

4. Written Informed Consent is given by the patient.

5. Compliance by the patient seems guaranteed, and patient seems to be able to understand and complete the patient diary.

6. Patient able to remain at the doctor's practice for the initial 3 hours follo wing the first intake of study medication, and able to return for the study visi ts.

EXCLUSION CRITERIA

1. Female patients of child-bearing potential that are:

1. Pregnant

2. Currently breastfeeding

3. NOT practicing acceptable methods of birth control, or NOT planning to contin ue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implan table, injectable contraceptives or double-barrier method.

2. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate).

3. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago.

4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.

5. Patient who in the past week, or during the study will require treatment with the following: antibiotics steroids for oral, inhaling or topical application expectorants or antitussives. No physical therapy (e.g. throat compress, throa t rinsing) may be applied during the trial. Patients who have used analgesics or anti-inflammatory agents less than two half-lives of the applicable drug before study entry, or who will require their use in the 3 hours after taking the firs t lozenge.

6. Patients with mouth breathing as a result of nasal congestion.

7. Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.

8. Existing tumour condition currently under treatment.

9. Alcohol, and/or drug abuse.

10. Any clinical condition which, in the opinion of the investigator would not a llow safe completion of the protocol and safe administration of trial medication.

11. Any investigational therapy within 30 days prior to randomisation.