Clinical trial NCT01361802: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pharyngitis
Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2011-05-27
Enrollment: 494
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 2 hours
Secondary outcomes:
measure: 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
timeFrame: 3 hours
measure: 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
timeFrame: 4, 6, 12 and 24 hours
measure: Patient assessment of efficacy at 3 and 24 hours after the first spray application will be assessed on a 5-point verbal rating scale.
timeFrame: 3 and 24 hours
Other outcomes:
Locations:
city: Bloemfontein
country: South Africa
facility: 18.504.27015 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 18.504.27005 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 18.504.27011 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 18.504.27013 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 18.504.27014 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 18.504.27008 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 18.504.27010 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 18.504.27001 Boehringer Ingelheim Investigational Site
city: Klipspruit West
country: South Africa
facility: 18.504.27004 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 18.504.27003 Boehringer Ingelheim Investigational Site
city: Lenasia
country: South Africa
facility: 18.504.27002 Boehringer Ingelheim Investigational Site
city: Newtown
country: South Africa
facility: 18.504.27006 Boehringer Ingelheim Investigational Site
city: Paarl
country: South Africa
facility: 18.504.27012 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 18.504.27007 Boehringer Ingelheim Investigational Site
city: Sydenham
country: South Africa
facility: 18.504.27009 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: