Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
1 other identifier
interventional
751
2 countries
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2005
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedDecember 28, 2017
December 1, 2017
8 months
September 7, 2005
December 27, 2017
Conditions
Outcome Measures
Primary Outcomes (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)
Secondary Outcomes (1)
Pain intensity (PI) and pain intensity difference from pre-dose baseline (PID) Time to onset of action after the first lozenge Assessment of efficacy Assessment of tolerability by the patient and investigator Adverse events
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- Patients with mouth breathing as a result of nasal congestion.
- Known hypersensitivity to Ambroxol or to auxiliary substances contained in t he lozenge.
- Existing tumour condition currently under treatment.
- Alcohol, and/or drug abuse.
- Any clinical condition which, in the opinion of the investigator would not a llow safe completion of the protocol and safe administration of trial medication.
- Any investigational therapy within 30 days prior to randomisation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Medicover
Bucharest, 010224, Romania
Medicover
Bucharest, 010626, Romania
Medicover
Bucharest, 021106, Romania
Victor Babes Clincial Hospital
Bucharest, 030303, Romania
Regional Student Hospital
Kharkiv, 61002, Ukraine
Regional Clinical Hospital
Kharkiv, 61022, Ukraine
City Clinical Otolaryngological Hospital
Kharkiv, 61024, Ukraine
City Clinical Hospital No. 17
Kharkiv, 61037, Ukraine
City Clinical Hospital No. 11
Kharkiv, 61050, Ukraine
City Clinical Hospital No. 26
Kharkiv, 61072, Ukraine
Academy of Medical Science named after O.S. Kolomyichenko
Kiev, 03057, Ukraine
City Clinical Hospital No. 9
Kiev, 04112, Ukraine
City Clinical Hospital No. 11
Odesa, 65006, Ukraine
Regional Clinical Hospital
Zaporizhzhya, 69600, Ukraine
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
BI Pharma Ges mbH Wien
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 8, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
December 28, 2017
Record last verified: 2017-12