Trials / Completed
CompletedNCT03583658
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 390 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Duration per participant is up to 4 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ambroxol BIH1526 | Pharmaceutical form: lozenges Route of administration: oromucosal |
| DRUG | placebo | Pharmaceutical form: lozenges Route of administration: oromucosal |
Timeline
- Start date
- 2018-06-30
- Primary completion
- 2018-09-02
- Completion
- 2018-09-02
- First posted
- 2018-07-11
- Last updated
- 2022-04-25
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT03583658. Inclusion in this directory is not an endorsement.