Clinical Trials Logo
  1. Home
  2. Pharyngitis
  3. NCT00148499

Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis

Pharyngitis Clinical Trial

Official title:
Efficacy and Tolerability of Ambroxol Lozenge 20 mg in Relieving Pain of Sore Throat in Patients With Acute Viral Pharyngitis-A Randomised, Double-blind,Placebo- and Active-controlled Parallel Group Study

Clinical Trial 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.

Clinical Trial Description

This is a randomised, double-blind, placebo- and active-controlled parallel group study in adult pat ients, suffering from acute viral pharyngitis and throat pain of at least moderate intensity.

The whole study will last for up to 4 days, on each of test days patients will take one lozenge cont aining Ambroxol hydrochlorid 20 mg/ or placebo/ or benzocaine lozenge 3 mg up to 6 lozenges per day.

Using Patient Diaries the assessment of tolerability and efficacy by the patient will be obtained.

Study Hypothesis:

The primary hypothesis to be tested is the test of superiority of ambroxol 20 mg in comparison to placebo. If and only if the corresponding test of superiority to placebo is statistically significant, the hypothesis of non-inferiority of am broxol 20 mg in comparison to benzocaine 3 mg will be tested.

Comparison(s):

For the primary comparison the placebo lozenges will be used, for the secondary comparison the benzocaine 3 mg lozenges will be used. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00148499
Study type Interventional
Source Boehringer Ingelheim
Contact
Status Completed
Phase Phase 3
Start date October 2005
Completion date June 2006
View Details
See also
  Status Clinical Trial Phase
Completed NCT01453400 - Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain Phase 3
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Recruiting NCT01681667 - Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain Phase 4
Completed NCT00527852 - Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis N/A
Completed NCT02178293 - Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride Phase 4
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Withdrawn NCT02535962 - Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA) Phase 2
Not yet recruiting NCT02252419 - Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat N/A
Completed NCT00798018 - Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena N/A
Completed NCT00535093 - An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel N/A
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Recruiting NCT06027593 - Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions N/A
Recruiting NCT03720301 - The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat N/A
Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Completed NCT01398696 - Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour Phase 4
Completed NCT01049334 - A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis Phase 3
Completed NCT01048866 - A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis Phase 3
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3
Completed NCT01465009 - Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold Phase 4