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Ambroxol Spray Sore Throat Study

Primary Purpose

Pharyngitis, Pain

Status
Completed
Phase
Phase 2
Locations
South Africa
Study Type
Interventional
Intervention
Ambroxol Spray
Ambroxol Spray
Ambroxol Spray
Placebo Spray
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 18.504.27015 Boehringer Ingelheim Investigational Site
  • 18.504.27005 Boehringer Ingelheim Investigational Site
  • 18.504.27011 Boehringer Ingelheim Investigational Site
  • 18.504.27013 Boehringer Ingelheim Investigational Site
  • 18.504.27014 Boehringer Ingelheim Investigational Site
  • 18.504.27008 Boehringer Ingelheim Investigational Site
  • 18.504.27010 Boehringer Ingelheim Investigational Site
  • 18.504.27001 Boehringer Ingelheim Investigational Site
  • 18.504.27004 Boehringer Ingelheim Investigational Site
  • 18.504.27003 Boehringer Ingelheim Investigational Site
  • 18.504.27002 Boehringer Ingelheim Investigational Site
  • 18.504.27006 Boehringer Ingelheim Investigational Site
  • 18.504.27012 Boehringer Ingelheim Investigational Site
  • 18.504.27007 Boehringer Ingelheim Investigational Site
  • 18.504.27009 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Ambroxol Spray 2.5mg

Ambroxol Spray 5mg

Ambroxol Spray 10mg

Placebo Spray

Arm Description

Ambroxol Spray Low Dose

Ambroxol Spray Medium Dose

Ambroxol Spray High dose

Placebo Spray

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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
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
Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.

Full Information

First Posted
May 16, 2011
Last Updated
April 30, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01361802
Brief Title
Ambroxol Spray Sore Throat Study
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngitis, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambroxol Spray 2.5mg
Arm Type
Active Comparator
Arm Description
Ambroxol Spray Low Dose
Arm Title
Ambroxol Spray 5mg
Arm Type
Active Comparator
Arm Description
Ambroxol Spray Medium Dose
Arm Title
Ambroxol Spray 10mg
Arm Type
Active Comparator
Arm Description
Ambroxol Spray High dose
Arm Title
Placebo Spray
Arm Type
Placebo Comparator
Arm Description
Placebo Spray
Intervention Type
Drug
Intervention Name(s)
Ambroxol Spray
Intervention Description
low dose Ambroxol Spray
Intervention Type
Drug
Intervention Name(s)
Ambroxol Spray
Intervention Description
medium dose Ambroxol Spray
Intervention Type
Drug
Intervention Name(s)
Ambroxol Spray
Intervention Description
high dose Ambroxol Spray
Intervention Type
Drug
Intervention Name(s)
Placebo Spray
Intervention Description
Placebo Spray
Primary Outcome Measure Information:
Title
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).
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
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
Time Frame
3 hours
Title
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
Time Frame
4, 6, 12 and 24 hours
Title
Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.
Time Frame
3 and 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Sore throat due to acute pharyngitis (not more than 72 hours); Score of 6 or greater on an 11-point pain intensity numerical rating scale; Willingness to remain at the study centre for one hour following the first dose of study medication and return one to three days later. 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: Known allergy to and/or hypersensitivity to ambroxol, sorbitol, or Acetaminophen; Patients with drug dependence and/or alcohol abuse; Use of any throat lozenge, throat spray, cough drop, menthol-containing product, or any product with demulcent properties within last 2 hours; Use of any analgesic/anti-pyretic within last 4 hours; Use of any "cold medication" (e.g. decongestant, antihistamine, expectorant, anti-tussive) within last eight hours; Use of an antibiotic for an acute illness within last 24 hours; Use of inhaled steroids or beta-agonists on a continuous basis during the last week; Use of any investigational therapy (including a marketed drug taken for an investigational indication) within last 30 days Any sign of mouth-breathing due to nasal congestion; Cough that causes throat discomfort; Active pulmonary disease such as bronchopneumonia; Pregnant, lactating or breastfeeding women, 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. Patients who have previously enrolled in this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
18.504.27015 Boehringer Ingelheim Investigational Site
City
Bloemfontein
Country
South Africa
Facility Name
18.504.27005 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
18.504.27011 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
18.504.27013 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
18.504.27014 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
18.504.27008 Boehringer Ingelheim Investigational Site
City
Durban
Country
South Africa
Facility Name
18.504.27010 Boehringer Ingelheim Investigational Site
City
Durban
Country
South Africa
Facility Name
18.504.27001 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
18.504.27004 Boehringer Ingelheim Investigational Site
City
Klipspruit West
Country
South Africa
Facility Name
18.504.27003 Boehringer Ingelheim Investigational Site
City
Krugersdorp
Country
South Africa
Facility Name
18.504.27002 Boehringer Ingelheim Investigational Site
City
Lenasia
Country
South Africa
Facility Name
18.504.27006 Boehringer Ingelheim Investigational Site
City
Newtown
Country
South Africa
Facility Name
18.504.27012 Boehringer Ingelheim Investigational Site
City
Paarl
Country
South Africa
Facility Name
18.504.27007 Boehringer Ingelheim Investigational Site
City
Pretoria
Country
South Africa
Facility Name
18.504.27009 Boehringer Ingelheim Investigational Site
City
Sydenham
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/18/18.504_U12-1233-01.pdf
Description
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Ambroxol Spray Sore Throat Study

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