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

Pharyngitis Clinical Trial

Official title:

Efficacy and Tolerability of Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis - A Randomised, Double-blind, Placebo-controlled Parallel Group Study. AMBROSIA: Ambroxol Lozenges In Sore Throat In Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00144274
• Other study ID #: 18.487
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: October 28, 2013
• Start date: April 2005
• Est. completion date: November 2005

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council (MCC)
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Drug:
• Ambroxol Lozenge

Locations

Country	Name	City	State
South Africa	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the 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 Time to onset of action of lozenge Assessment of redness of pharyngeal mucosa at pre-dose baseline and end of study Efficacy and tolerability assessment Adverse events

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