Ambroxol Spray Sore Throat Study

Phase 2

Completed

• Conditions: Pharyngitis; Pain
• Interventions: Drug: Ambroxol Spray; Drug: Placebo Spray

• Registration Number: NCT01361802
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-27
• Primary Completion: 2011-08
• Status Verified: 2014-04
• Disposition First Submitted: 2014-04-30
• Disposition First Submitted QC: 2014-04-30
• Last Update Submitted: 2014-04-30
• Disposition First Posted: 2014-05-16
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 494

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ambroxol Spray 2.5mg	Ambroxol Spray	Ambroxol Spray Low Dose
Ambroxol Spray 5mg	Ambroxol Spray	Ambroxol Spray Medium Dose
Ambroxol Spray 10mg	Ambroxol Spray	Ambroxol Spray High dose
Placebo Spray	Placebo Spray	Placebo Spray

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the time-weighted average of the pain intensity difference (PID) from pre-dose baseline over the first two hours after the first spray application expressed as a ratio of the pre-dose baseline (SPIDnorm0-2h).	2 hours

Secondary Outcome Measures

Name	Time	Method
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 3 hours after the first spray application and the corresponding SPIDnorm0-3h	3 hours
Patients will record their pain intensity on the 11-point ordinal numerical rating scale in the diary additionally at 4, 6, 12 and 24 hours after the first spray application and the corresponding SPIDnorm0-24h	4, 6, 12 and 24 hours
Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.	3 and 24 hours

Trial Locations

Locations (15)

18.504.27015 Boehringer Ingelheim Investigational Site; 🇿🇦 Bloemfontein, South Africa

18.504.27005 Boehringer Ingelheim Investigational Site; 🇿🇦 Cape Town, South Africa

18.504.27011 Boehringer Ingelheim Investigational Site; 🇿🇦 Cape Town, South Africa

18.504.27013 Boehringer Ingelheim Investigational Site; 🇿🇦 Cape Town, South Africa

18.504.27014 Boehringer Ingelheim Investigational Site; 🇿🇦 Cape Town, South Africa

18.504.27010 Boehringer Ingelheim Investigational Site; 🇿🇦 Durban, South Africa

18.504.27001 Boehringer Ingelheim Investigational Site; 🇿🇦 Johannesburg, South Africa

18.504.27003 Boehringer Ingelheim Investigational Site; 🇿🇦 Krugersdorp, South Africa

18.504.27002 Boehringer Ingelheim Investigational Site; 🇿🇦 Lenasia, South Africa

18.504.27012 Boehringer Ingelheim Investigational Site; 🇿🇦 Paarl, South Africa

18.504.27007 Boehringer Ingelheim Investigational Site; 🇿🇦 Pretoria, South Africa

18.504.27008 Boehringer Ingelheim Investigational Site; 🇿🇦 Durban, South Africa

18.504.27004 Boehringer Ingelheim Investigational Site; 🇿🇦 Klipspruit West, South Africa

18.504.27006 Boehringer Ingelheim Investigational Site; 🇿🇦 Newtown, South Africa

18.504.27009 Boehringer Ingelheim Investigational Site; 🇿🇦 Sydenham, South Africa