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CompletedNCT01361802Updated May 16, 2014

Ambroxol Spray Sore Throat Study

A Phase 2 interventional study of Ambroxol Spray and Ambroxol Spray in Pharyngitis and Pain, sponsored by Boehringer Ingelheim. Completed at 15 sites in South Africa. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-16.

Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
494
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pharyngitis
  • Pain

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03

In context

Pharyngitis

252 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.

This study's enrollment of 494 is above the median of 144 across 209 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
494 participants (actual)

Study arms

  • Active comparator
    Ambroxol Spray 2.5mg

    Ambroxol Spray Low Dose

    Drug: Ambroxol Spray

  • Active comparator
    Ambroxol Spray 5mg

    Ambroxol Spray Medium Dose

    Drug: Ambroxol Spray

  • Active comparator
    Ambroxol Spray 10mg

    Ambroxol Spray High dose

    Drug: Ambroxol Spray

  • Placebo comparator
    Placebo Spray

    Placebo Spray

    Drug: Placebo Spray

Interventions

  • DrugAmbroxol Spray

    low dose Ambroxol Spray

  • DrugAmbroxol Spray

    medium dose Ambroxol Spray

  • DrugAmbroxol Spray

    high dose Ambroxol Spray

  • DrugPlacebo Spray

    Placebo Spray

06

What researchers measure

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).

    Time frame: 2 hours

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

15 sites
  • 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, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01361802
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 27, 2011
Start date
May 2011
Primary completion
Aug 2011
Last update
May 16, 2014

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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