NCT01361802

Ambroxol Spray Sore Throat Study

A Multi-centre, Randomised, Double-blind, Placebo Controlled Parallel Group, Dose Finding Study to Assess the Efficacy and Safety of Ambroxol Spray (2.5mg, 5mg or 10mg) Versus Placebo for the Temporary Relief of Sore Throat Pain in Patients With Acute Pharyngitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 494 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The development of a new Ambroxol spray formulation for the treatment of sore throat pain associated with acute pharyngitis requires an initial phase II study to be conducted in order to select the most appropriate dose for pain relief.

Conditions

• Pharyngitis
• Pain

Interventions

Type	Name	Description
DRUG	Ambroxol Spray	low dose Ambroxol Spray
DRUG	Ambroxol Spray	medium dose Ambroxol Spray
DRUG	Ambroxol Spray	high dose Ambroxol Spray
DRUG	Placebo Spray	Placebo Spray

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-08-01
• First posted: 2011-05-27
• Last updated: 2014-05-16

Locations

15 sites across 1 country: South Africa