Pharyngitis Clinical Trial
Official title:
Efficacy and Tolerability of Ambroxol Lozenge 20 mg in Relieving Pain of Sore Throat in Patients With Acute Viral Pharyngitis-A Randomised, Double-blind,Placebo- and Active-controlled Parallel Group Study
Verified date | December 2017 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 751 |
Est. completion date | June 2006 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Romania | Medicover | Bucharest | |
Romania | Medicover | Bucharest | |
Romania | Medicover | Bucharest | |
Romania | Victor Babes Clincial Hospital | Bucharest | |
Ukraine | City Clinical Hospital No. 11 | Kharkov | |
Ukraine | City Clinical Hospital No. 17 | Kharkov | |
Ukraine | City Clinical Hospital No. 26 | Kharkov | |
Ukraine | City Clinical Otolaryngological Hospital | Kharkov | |
Ukraine | Regional Clinical Hospital | Kharkov | |
Ukraine | Regional Student Hospital | Kharkov | |
Ukraine | Academy of Medical Science named after O.S. Kolomyichenko | Kiev | |
Ukraine | City Clinical Hospital No. 9 | Kiev | |
Ukraine | City Clinical Hospital No. 11 | Odessa | |
Ukraine | Regional Clinical Hospital | Zaporozhye |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Romania, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Endpoint: Time-weighted average of the pain intensity difference from pre-dose baseline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline (SPIDnorm) | |||
Secondary | Pain intensity (PI) and pain intensity difference from pre-dose baseline (PID) Time to onset of action after the first lozenge Assessment of efficacy Assessment of tolerability by the patient and investigator Adverse events |
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