CompletedPhase 3

Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat

China249 participantsStarted 2007-08-01

Plain-language summary

The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

Who can participate

Age range

16 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

1\. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed. 1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate). 2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already. 3. Counting of white blood cell in blood routine examination exceeds 10?109/L. 4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 5. Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage). 6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet. 7. Previous and/or existing tumour condition. 8. Pregnancy and/or breast-feeding. 9. Alcohol, and/or drug abuse. 10. Simultaneous participation in another clinical trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline

Timeframe: pre-dose baseline and 30, 60, 120, and 180 minutes

Trial details

NCT IDNCT00525044

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-01-01

Results submitted2018-12-20

View on ClinicalTrials.gov More Pharyngitis trials

Who can participate

Age range

16 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.