Status:
COMPLETED
Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pharyngitis
Eligibility:
All Genders
12-18 years
Phase:
PHASE3
Brief Summary
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients su...
Detailed Description
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients su...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients having a sore throat with acute viral pharyngitis.
- Female and male patients from 12 and less than 18 years of age.
- The throat pain intensity is rated at least "moderate" on the VRS(PI).
- Written Informed Consent is given by the patient's parent/legal guardian, an d the patient is able to give Assent.
- Compliance by the patient seems guaranteed, and the 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, or known reliable patient, and able t o return for the study visits.
- EXCLUSION CRITERIA
- Female patients who have begun menstruating and are:
- Pregnant
- Currently breastfeeding
- Of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implantable or injectable contraceptives. Abstinenc e can be used as contraception, at the discretion of the investigator.
- 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 analgesics anti-inflammatory agents steroids fo r oral, inhaling or topical application expectorants or antitussives. No phys ical therapy (e.g. throat compress) may be applied during the trial.
- Patients with mouth breathing as a result of nasal congestion.
- Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.
- Previous and/or existing tumour condition.
- 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 :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00144274
Start Date
April 1 2005
End Date
November 1 2005
Last Update
October 29 2013
Active Locations (12)
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1
Boehringer Ingelheim Investigational Site
Boksburg, South Africa, 1461
2
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7646
3
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7700
4
Boehringer Ingelheim Investigational Site
Cape Town, South Africa, 7945