Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis (DELICIOUS)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Pharyngitis

Treatments: Drug: placebo; Drug: ambroxol BIH1526

Study type: Interventional

Funder types: Industry

Identifiers

NCT03583658

U1111-1202-9392 (Other Identifier)

LPS15328

Details and patient eligibility

About

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.

Full description

Duration per participant is up to 4 days.

Enrollment: 390 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.
• Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.
• Signed written informed consent.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

390 participants in 2 patient groups, including a placebo group

Ambroxol hydrochloride (BIH1526)

Active Comparator group

Description:

One lozenge 20 mg on as-needed basis, up to 6 times per day

Treatment:

Drug: ambroxol BIH1526

Placebo

Placebo Comparator group

Description:

One lozenge on as-needed basis, up to 6 times per day

Treatment:

Drug: placebo