Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With… (NCT00148499) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
Romania, Ukraine751 participantsStarted 2005-10
Plain-language summary
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20 mg a mbroxol hydrochloride (Mucoangin?) relative to lozenges containing placebo and lozenges containing 3 mg benzocaine in relieving pain of sore throat in patients suffering from acute viral pharyngitis.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients having a sore throat with acute viral pharyngitis.
✓. Female and male patients between the ages of 18 and 80 years.
✓. The throat pain intensity is rated at least moderate on the VRS (PI).
✓. Written Informed Consent is given by the patient.
✓. Compliance by the patient seems guaranteed, and patient seems to be able to understand and complete the patient diary.
✓. Patient able to remain at the doctor's practice for the initial 3 hours follo wing the first intake of study medication, and able to return for the study visi ts.
Exclusion criteria
✕. Female patients of child-bearing potential that are:
✕. Pregnant
✕. Currently breastfeeding
✕. NOT practicing acceptable methods of birth control, or NOT planning to contin ue practicing an acceptable method throughout the study. Acceptable methods of birth control include surgical sterilisation, intra uterine device, oral, implan table, injectable contraceptives or double-barrier method.
✕. Patients with symptoms of primarily bacterial pharyngitis or bacterial secon dary infection (clinical findings inter alia assessment of exudate).
✕. First indication of symptoms of acute pharyngitis (e.g. sore throat) occurre d more than 3 days ago.
What they're measuring
1
Primary Endpoint: Time-weighted average of the pain intensity difference from pre-dose baseline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline (SPIDnorm)
✕. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks.
✕. Patient who in the past week, or during the study will require treatment with the following: antibiotics steroids for oral, inhaling or topical application expectorants or antitussives. No physical therapy (e.g. throat compress, throa t rinsing) may be applied during the trial. Patients who have used analgesics or anti-inflammatory agents less than two half-lives of the applicable drug before study entry, or who will require their use in the 3 hours after taking the firs t lozenge.