Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
494 participants
INTERVENTIONAL
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ambroxol Spray 2.5mg
Ambroxol Spray Low Dose
Ambroxol Spray
low dose Ambroxol Spray
Ambroxol Spray 5mg
Ambroxol Spray Medium Dose
Ambroxol Spray
medium dose Ambroxol Spray
Ambroxol Spray 10mg
Ambroxol Spray High dose
Ambroxol Spray
high dose Ambroxol Spray
Placebo Spray
Placebo Spray
Placebo Spray
Placebo Spray
Interventions
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Ambroxol Spray
low dose Ambroxol Spray
Ambroxol Spray
medium dose Ambroxol Spray
Ambroxol Spray
high dose Ambroxol Spray
Placebo Spray
Placebo Spray
Eligibility Criteria
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Inclusion Criteria
2. Score of 6 or greater on an 11-point pain intensity numerical rating scale;
3. Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later.
4. 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.
Exclusion Criteria
2. Patients with drug dependence and/or alcohol abuse;
3. Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours;
4. Use of any analgesic/anti-pyretic within last 4 hours;
5. Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours;
6. Use of an antibiotic for an acute illness within last 24 hours;
7. Use of inhaled steroids or beta-agonists on a continuous basis during the last week;
8. Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days
9. Any sign of mouth-breathing due to nasal congestion;
10. Cough that causes throat discomfort;
11. Active pulmonary disease such as bronchopneumonia;
12. Pregnant, lactating or breastfeeding women,
13. 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.
14. Patients who have previously enrolled in this study
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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18.504.27015 Boehringer Ingelheim Investigational Site
Bloemfontein, , South Africa
18.504.27005 Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
18.504.27011 Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
18.504.27013 Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
18.504.27014 Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
18.504.27008 Boehringer Ingelheim Investigational Site
Durban, , South Africa
18.504.27010 Boehringer Ingelheim Investigational Site
Durban, , South Africa
18.504.27001 Boehringer Ingelheim Investigational Site
Johannesburg, , South Africa
18.504.27004 Boehringer Ingelheim Investigational Site
Klipspruit West, , South Africa
18.504.27003 Boehringer Ingelheim Investigational Site
Krugersdorp, , South Africa
18.504.27002 Boehringer Ingelheim Investigational Site
Lenasia, , South Africa
18.504.27006 Boehringer Ingelheim Investigational Site
Newtown, , South Africa
18.504.27012 Boehringer Ingelheim Investigational Site
Paarl, , South Africa
18.504.27007 Boehringer Ingelheim Investigational Site
Pretoria, , South Africa
18.504.27009 Boehringer Ingelheim Investigational Site
Sydenham, , South Africa
Countries
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Other Identifiers
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18.504
Identifier Type: -
Identifier Source: org_study_id
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