Ambroxol Spray Sore Throat Study

NCT01361802 | Completed Phase 2

• 1 other identifier: 18.504
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 15

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.

Conditions

Pharyngitis; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

Ambroxol Spray 2.5mg

ACTIVE COMPARATOR

Ambroxol Spray Low Dose

Drug: Ambroxol Spray

Ambroxol Spray 5mg

ACTIVE COMPARATOR

Ambroxol Spray Medium Dose

Drug: Ambroxol Spray

Ambroxol Spray 10mg

ACTIVE COMPARATOR

Ambroxol Spray High dose

Drug: Ambroxol Spray

Placebo Spray

PLACEBO COMPARATOR

Placebo Spray

Drug: Placebo Spray

Interventions

Ambroxol Spray DRUG

low dose Ambroxol Spray

Ambroxol Spray 2.5mg

Placebo Spray DRUG

Placebo Spray

Placebo Spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (15)

18.504.27015 Boehringer Ingelheim Investigational Site

Bloemfontein, South Africa

Location

18.504.27005 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

18.504.27011 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

18.504.27013 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

18.504.27014 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

18.504.27008 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

18.504.27010 Boehringer Ingelheim Investigational Site

Durban, South Africa

Location

18.504.27001 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

18.504.27004 Boehringer Ingelheim Investigational Site

Klipspruit West, South Africa

Location

18.504.27003 Boehringer Ingelheim Investigational Site

Krugersdorp, South Africa

Location

18.504.27002 Boehringer Ingelheim Investigational Site

Lenasia, South Africa

Location

18.504.27006 Boehringer Ingelheim Investigational Site

Newtown, South Africa

Location

18.504.27012 Boehringer Ingelheim Investigational Site

Paarl, South Africa

Location

18.504.27007 Boehringer Ingelheim Investigational Site

Pretoria, South Africa

Location

18.504.27009 Boehringer Ingelheim Investigational Site

Sydenham, South Africa

Location

MeSH Terms

Conditions

Pharyngitis; Pain

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 27, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2011
• Last Updated: May 16, 2014

Record last verified: 2014-04

Locations

ZA (15)