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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1202-9392 | Other Identifier | UTN |
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Primary Objective:
To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis.
Secondary Objective:
To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis.
Duration per participant is up to 4 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambroxol hydrochloride (BIH1526) | Active Comparator | One lozenge 20 mg on as-needed basis, up to 6 times per day |
|
| Placebo | Placebo Comparator | One lozenge on as-needed basis, up to 6 times per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ambroxol BIH1526 | Drug | Pharmaceutical form: lozenges Route of administration: oromucosal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity difference (PID) | Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h) | hour 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in SPID | Change from baseline to hour 24 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-24h) | hour 24 |
| 3-hour patient assessment of efficacy |
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Inclusion criteria:
Exclusion criteria:
Patients suffering from pharyngitis of bacterial origin.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number 7100005 | Johannesburg | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32026411 | Derived | Sousa R, Lakha DR, Brette S, Hitier S. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis. Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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| ID | Term |
|---|---|
| D010612 | Pharyngitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
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| placebo | Drug | Pharmaceutical form: lozenges Route of administration: oromucosal |
|
Patient assessment of efficacy after 3 hours of the first study drug intake using a 5-point verbal rating scale (VRS) to rate whether the trial medication relieves sore throat pain, where 0 = poor and 4 = excellent
| hour 3 |
| 24-hour patient assessment of efficacy | Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS | hour 24 |
| Adverse events | Incidence of the adverse events | baseline to day 4 |
| Patient assessment of tolerability | Patient assessment of tolerability after 3 hours, Day 1, on Day 2, Day 3 and Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent | hour 3, hour 24 and day 2, day 3 or day 4 |
| Final assessment of tolerability | Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent | day 4 |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |