Ambroxol Spray Sore Throat Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361802
• Other study ID #: 18.504
• Status: Completed
• Phase: Phase 2
• First received: May 16, 2011
• Last updated: April 30, 2014
• Start date: May 2011

Study information

• Verified date: April 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Sore throat due to acute pharyngitis (not more than 72 hours);

2. Score of 6 or greater on an 11-point pain intensity numerical rating scale;

3. Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later.

4. Willing to take nothing by mouth except study medication for three hours following the first intake of study medication. Patients must also not smoke during this time period.

Exclusion criteria:

1. Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen;

2. Patients with drug dependence and/or alcohol abuse;

3. Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours;

4. Use of any analgesic/anti-pyretic within last 4 hours;

5. Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours;

6. Use of an antibiotic for an acute illness within last 24 hours;

7. Use of inhaled steroids or beta-agonists on a continuous basis during the last week;

8. Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days

9. Any sign of mouth-breathing due to nasal congestion;

10. Cough that causes throat discomfort;

11. Active pulmonary disease such as bronchopneumonia;

12. Pregnant, lactating or breastfeeding women,

13. Any medical or psychiatric condition which, in the opinion of the investigator, could increase the risks associated with participation in an investigational study or affect compliance with the protocol.

14. Patients who have previously enrolled in this study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pharyngitis

Intervention

Drug:
• Ambroxol Spray
low dose Ambroxol Spray
• Ambroxol Spray
medium dose Ambroxol Spray
• Ambroxol Spray
high dose Ambroxol Spray
• Placebo Spray
Placebo Spray

Locations

Country	Name	City	State
South Africa	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	18.504.27008 Boehringer Ingelheim Investigational Site	Durban
South Africa	18.504.27010 Boehringer Ingelheim Investigational Site	Durban
South Africa	18.504.27001 Boehringer Ingelheim Investigational Site	Johannesburg
South Africa	18.504.27004 Boehringer Ingelheim Investigational Site	Klipspruit West
South Africa	18.504.27003 Boehringer Ingelheim Investigational Site	Krugersdorp
South Africa	18.504.27002 Boehringer Ingelheim Investigational Site	Lenasia
South Africa	18.504.27006 Boehringer Ingelheim Investigational Site	Newtown
South Africa	18.504.27012 Boehringer Ingelheim Investigational Site	Paarl
South Africa	18.504.27007 Boehringer Ingelheim Investigational Site	Pretoria
South Africa	18.504.27009 Boehringer Ingelheim Investigational Site	Sydenham

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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