NCT00144274|CompletedPhase 3

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

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

Boehringer Ingelheim ClinicalTrials.gov

Compare

1 other identifier

18.487

Study Type

interventional

Target

220

Locations

1 country

Sites

Timeline

RegisteredSep 2005

StartedApr 2005

CompletionNov 2005

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

220

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Apr 2005

Shorter than P25 for phase_3

Geographic Reach

1 country

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

April 1, 2005

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed

Last Updated

October 29, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

September 2, 2005

Last Update Submit

October 28, 2013

Conditions

Pharyngitis

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Interventions

Ambroxol LozengeDRUG

Eligibility Criteria

Age12 Years - 18 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.