PharyngitisPhase 3NCT00144274
Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis
A Phase 3 study testing Ambroxol Lozenge in people with Pharyngitis, run by Boehringer Ingelheim at 12 sites in South Africa.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Ambroxol Lozenge
- How many people
- 220 participants
- Where
- 12 sitesSouth Africa
- Study dates
- Apr 2005to Nov 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Africa12 sites
Boehringer Ingelheim Investigational Site
Boksburg, 1461
Boehringer Ingelheim Investigational Site
Cape Town, 7646
Boehringer Ingelheim Investigational Site
Cape Town, 7700
Boehringer Ingelheim Investigational Site
Cape Town, 7945
Boehringer Ingelheim Investigational Site
Durban, 4091
Boehringer Ingelheim Investigational Site
Johannesburg, 2033
Boehringer Ingelheim Investigational Site
Johannesburg, 2192
Boehringer Ingelheim Investigational Site
Krugersdorp, 1739
Boehringer Ingelheim Investigational Site
Midrand, 1685
Boehringer Ingelheim Investigational Site
Pretoria, 0038
Boehringer Ingelheim Investigational Site
Pretoria, 0157
Boehringer Ingelheim Investigational Site
Sandton, 2021
About this study
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
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).
Read the 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
- Being tested
- Ambroxol Lozenge
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambroxol LozengeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. South Africa (Pty.) Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00144274
- Sponsor's protocol ID
- 18.487
- Status last verified
- Oct 2013
- First submitted
- 2 Sep 2005
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00144274
- Acronym / sponsor ID
- 18.487
- Conditions
- Pharyngitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005
- First posted
- 5 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- Female patients who have begun menstruating and are:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambroxol Lozenge | Drug | – |
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Related trials for Pharyngitis
Not yet recruiting
Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
Airway Complication of Anesthesia, Hemodynamic Instability
RecruitingPhase 4
A Single Dose of Intravenous Penicillin as an Adjunct to Oral Penicillin in the Treatment of Acute Tonsillitis, Peritonsillar Phlegmon, and Peritonsillar Abscess
Acute Tonsillitis, Peritonsillar Abscess
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. South Africa (Pty.) Ltd.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ambroxol Lozenge in people with Pharyngitis, run by Boehringer Ingelheim at 12 sites in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.