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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00144274 |
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The primary endpoint is the time-weighted average of the pain intensity difference from pre-dose bas eline over the first 3 hours after the first lozenge expressed as a ratio of the pre-dose baseline ( SPIDnorm).
Condition | Intervention | Phase |
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Pharyngitis |
Drug: Ambroxol Lozenge |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy and Tolerance of Ambroxol Lozenges (20 mg) in the Treatment of Sore Throat in Adolescent Patients With Acute Sore Throat |
Estimated Enrollment: | 220 |
Estimated Study Completion Date: | November 2005 |
The purpose of this trial is to investigate efficacy and tolerability of lozenges containing 20mg am broxol hydrochloride relative to placebo in relieving pain of sore throat in adolescent patients suf fering from acute viral pharyngitis. The pain intensity will be assessed by the patient on a 6-point rating scale before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter. The patient enters the rating in the patient's diary.
Study Hypothesis:
It will be tested whether a statistically significant difference exists in the S PIDnorm after the intake of the 1st lozenge between the group treated with ambro xol lozenges and the group treated with placebo lozenges.
Comparison(s):
Placebo comparison
Ages Eligible for Study: | 12 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA
Patient able to remain at the doctor's practice for the initial 3 hours follo wing the first intake of study medication, or known reliable patient, and able t
EXCLUSION CRITERIA
Female patients who have begun menstruating and are:
South Africa | |
Boehringer Ingelheim Investigational Site | |
Midrand, South Africa, 1685 | |
Boehringer Ingelheim Investigational Site | |
Pretoria, South Africa, 0038 | |
Boehringer Ingelheim Investigational Site | |
Pretoria, South Africa, 0157 | |
Boehringer Ingelheim Investigational Site | |
Johannesburg, South Africa, 2033 | |
Boehringer Ingelheim Investigational Site | |
Johannesburg, South Africa, 2192 | |
Boehringer Ingelheim Investigational Site | |
Krugersdorp, South Africa, 1739 | |
Boehringer Ingelheim Investigational Site | |
Durban, South Africa, 4091 | |
Boehringer Ingelheim Investigational Site | |
Sandton, South Africa, 2021 | |
Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa, 7646 | |
Boehringer Ingelheim Investigational Site | |
Boksburg, South Africa, 1461 | |
Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa, 7700 | |
Boehringer Ingelheim Investigational Site | |
Cape Town, South Africa, 7945 |
Study Chair: | Boehringer Ingelheim Study Coordinator | B.I. South Africa (Pty.) Ltd. |
Study ID Numbers: | 18.487 |
Study First Received: | September 2, 2005 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00144274 History of Changes |
Health Authority: | South Africa: Medicines Control Council (MCC) |
Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Expectorants Pain |
Stomatognathic Diseases Pharyngitis Ambroxol Pharyngeal Diseases |
Respiratory System Agents Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Expectorants |
Stomatognathic Diseases Pharyngitis Ambroxol Pharyngeal Diseases Pharmacologic Actions |