Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis

NCT ID: NCT00144274

Last Updated: 2013-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2005-11-30

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 suf fering from acute viral pharyngitis. The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose bas eline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).

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 suf fering from acute viral pharyngitis. The pain intensity will be assessed by the patient on a 6-point rating scale before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter. The patient enters the rating in the patient's diary.

Study Hypothesis:

It will be tested whether a statistically significant difference exists in the S PIDnorm after the intake of the 1st lozenge between the group treated with ambro xol lozenges and the group treated with placebo lozenges.

Comparison(s):

Placebo comparison

Conditions

Pharyngitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Ambroxol Lozenge

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Female and male patients from 12 and less than 18 years of age.

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

4. Written Informed Consent is given by the patient's parent/legal guardian, an d the patient is able to give Assent.

5. Compliance by the patient seems guaranteed, and the 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, or known reliable patient, and able t o return for the study visits.

Exclusion Criteria

1. Female patients who have begun menstruating and are:

1. Pregnant

2. Currently breastfeeding

3. 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.

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 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.

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. Previous and/or existing tumour condition.

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. South Africa (Pty.) Ltd.

Locations

Boehringer Ingelheim Investigational Site

Boksburg, , South Africa

Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Boehringer Ingelheim Investigational Site

Durban, , South Africa

Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

Boehringer Ingelheim Investigational Site

Krugersdorp, , South Africa

Boehringer Ingelheim Investigational Site

Midrand, , South Africa

Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Boehringer Ingelheim Investigational Site

Sandton, , South Africa

Countries

South Africa

Other Identifiers

18.487

Identifier Type: -

Identifier Source: org_study_id