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Completed

NCT Number: NCT01361802

Ambroxol Spray Sore Throat Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

18.504.27015 Boehringer Ingelheim Investigational Site, Bloemfontein, South Africa

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambroxol Spray

Drug

low dose Ambroxol Spray

Placebo Spray

Drug

Placebo Spray

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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
First posted
May 27, 2011
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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