Status:
COMPLETED
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pharyngitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
This is a randomised, double-blind, placebo- and active-controlled parallel group study in adult pat ients, suffering from acute viral pharyngitis and throat pain of at least moderate intensity. The ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients having a sore throat with acute viral pharyngitis.
- Female and male patients between the ages of 18 and 80 years.
- The throat pain intensity is rated at least moderate on the VRS (PI).
- Written Informed Consent is given by the patient.
- Compliance by the patient seems guaranteed, and patient seems to be able to understand and complete the patient diary.
- 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
- Female patients of child-bearing potential that are:
- Pregnant
- Currently breastfeeding
- 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.
- Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate).
- First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago.
- Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
- 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.
- Patients with mouth breathing as a result of nasal congestion.
- Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.
- Existing tumour condition currently under treatment.
- Alcohol, and/or drug abuse.
- 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.
- Any investigational therapy within 30 days prior to randomisation.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT00148499
Start Date
October 1 2005
End Date
June 1 2006
Last Update
December 28 2017
Active Locations (14)
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1
Medicover
Bucharest, Romania, 010224
2
Medicover
Bucharest, Romania, 010626
3
Medicover
Bucharest, Romania, 021106
4
Victor Babes Clincial Hospital
Bucharest, Romania, 030303