PharyngitisPhase 2NCT01361802
Ambroxol Spray Sore Throat Study
A Phase 2 study testing Ambroxol Spray in people with Pharyngitis and Pain, run by Boehringer Ingelheim at 15 sites in South Africa.
Trial summary
The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngitis, Pain
- What is being tested?
- Ambroxol Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 494 participants
- Where
- 15 sitesSouth Africa
- Study dates
- May 2011to Aug 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sore throat due to acute pharyngitis (not more than 72 hours);
- Score of 6 or greater on an 11-point pain intensity numerical rating scale;
- Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later.
- Willing to take nothing by mouth except study medication for three hours following the first intake of study medication. Patients must also not smoke during this time period.
Who cannot join
- Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen;
- Patients with drug dependence and/or alcohol abuse;
- Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours;
- Use of any analgesic/anti-pyretic within last 4 hours;
- Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours;
- Use of an antibiotic for an acute illness within last 24 hours;
Show all 14Show fewer
- Use of inhaled steroids or beta-agonists on a continuous basis during the last week;
- Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days
- Any sign of mouth-breathing due to nasal congestion;
- Cough that causes throat discomfort;
- Active pulmonary disease such as bronchopneumonia;
- Pregnant, lactating or breastfeeding women,
- Any medical or psychiatric condition which, in the opinion of the investigator, could increase the risks associated with participation in an investigational study or affect compliance with the protocol.
- Patients who have previously enrolled in this study
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
South Africa15 sites
18.504.27015 Boehringer Ingelheim Investigational Site
Bloemfontein
18.504.27005 Boehringer Ingelheim Investigational Site
Cape Town
18.504.27011 Boehringer Ingelheim Investigational Site
Cape Town
18.504.27013 Boehringer Ingelheim Investigational Site
Cape Town
18.504.27014 Boehringer Ingelheim Investigational Site
Cape Town
18.504.27008 Boehringer Ingelheim Investigational Site
Durban
18.504.27010 Boehringer Ingelheim Investigational Site
Durban
18.504.27001 Boehringer Ingelheim Investigational Site
Johannesburg
18.504.27004 Boehringer Ingelheim Investigational Site
Klipspruit West
18.504.27003 Boehringer Ingelheim Investigational Site
Krugersdorp
18.504.27002 Boehringer Ingelheim Investigational Site
Lenasia
18.504.27006 Boehringer Ingelheim Investigational Site
Newtown
18.504.27012 Boehringer Ingelheim Investigational Site
Paarl
18.504.27007 Boehringer Ingelheim Investigational Site
Pretoria
18.504.27009 Boehringer Ingelheim Investigational Site
Sydenham
About this study
Official title: A Multi-centre, Randomised, Double-blind, Placebo Controlled Parallel Group, Dose Finding Study to Assess the Efficacy and Safety of Ambroxol Spray (2.5mg, 5mg or 10mg) Versus Placebo for the Temporary Relief of Sore Throat Pain in Patients With Acute Pharyngitis
The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.
- Conditions
- Pharyngitis, Pain
- Being tested
- Ambroxol Spray, Placebo Spray
- Medical subject headings
- Pharyngitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambroxol SprayDrug
low dose Ambroxol Spray
Ambroxol SprayDrug
medium dose Ambroxol Spray
Ambroxol SprayDrug
high dose Ambroxol Spray
Placebo SprayDrug
Placebo Spray
| Study group | Role | What they receive |
|---|---|---|
| Ambroxol Spray 2.5mg | Active comparator | Ambroxol Spray Low Dose Receives: Drug: Ambroxol Spray |
| Ambroxol Spray 5mg | Active comparator | Ambroxol Spray Medium Dose Receives: Drug: Ambroxol Spray |
| Ambroxol Spray 10mg | Active comparator | Ambroxol Spray High dose Receives: Drug: Ambroxol Spray |
| Placebo Spray | Placebo comparator | Placebo Spray Receives: Drug: Placebo Spray |
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 (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h).
Measured: 2 hours
Secondary outcomes (3)
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 3 hours after the first spray application and the corresponding SPIDnorm0-3h
Measured: 3 hours
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 4, 6, 12 and 24 hours after the first spray application and the corresponding SPIDnorm0-24h
Measured: 4, 6, 12 and 24 hours
Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.
Measured: 3 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startMay 2011
- Primary completionAug 2011
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361802
- Sponsor's protocol ID
- 18.504
- Status last verified
- Apr 2014
- First submitted
- 16 May 2011
- Last updated
- 16 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Placebo Controlled Parallel Group, Dose Finding Study to Assess the Efficacy and Safety of Ambroxol Spray (2.5mg, 5mg or 10mg) Versus Placebo for the Temporary Relief of Sore Throat Pain in Patients With Acute Pharyngitis
- ClinicalTrials.gov ID
- NCT01361802
- Acronym / sponsor ID
- 18.504
- Conditions
- Pharyngitis, Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- First posted
- 27 May 2011 (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 development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ambroxol Spray 2.5mg | Active comparator | Drug: Ambroxol SprayAmbroxol Spray Low Dose |
| Ambroxol Spray 5mg | Active comparator | Drug: Ambroxol SprayAmbroxol Spray Medium Dose |
| Ambroxol Spray 10mg | Active comparator | Drug: Ambroxol SprayAmbroxol Spray High dose |
| Placebo Spray | Placebo comparator | Drug: Placebo SprayPlacebo Spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sore throat due to acute pharyngitis (not more than 72 hours);
- Score of 6 or greater on an 11-point pain intensity numerical rating scale;
- Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later.
- Willing to take nothing by mouth except study medication for three hours following the first intake of study medication. Patients must also not smoke during this time period.
Key exclusion criteria (14 listed)
- Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen;
- Patients with drug dependence and/or alcohol abuse;
- Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours;
- Use of any analgesic/anti-pyretic within last 4 hours;
- Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours;
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 Spraylow dose Ambroxol Spray | Drug | Ambroxol Spray 2.5mg |
| Ambroxol Spraymedium dose Ambroxol Spray | Drug | Ambroxol Spray 5mg |
| Ambroxol Sprayhigh dose Ambroxol Spray | Drug | Ambroxol Spray 10mg |
| Placebo SprayPlacebo Spray | Drug | Placebo Spray |
Primary outcome
The primary endpoint is the time-weighted average of the pain intensity difference (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h).
Time frame: 2 hours
3 secondary outcomes
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 3 hours after the first spray application and the corresponding SPIDnorm0-3h
Time frame: 3 hours
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 4, 6, 12 and 24 hours after the first spray application and the corresponding SPIDnorm0-24h
Time frame: 4, 6, 12 and 24 hours
Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.
Time frame: 3 and 24 hours
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 16 May 2014.
- Related InfoLink provided by the sponsor.
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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 chair
Boehringer Ingelheim
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ambroxol Spray in people with Pharyngitis and Pain, run by Boehringer Ingelheim at 15 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 4 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h). (time frame: 2 hours). 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 16 May 2014.