Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat

NCT00525044 | Completed Phase 3 Results

• 1 other identifier: 18.490
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this trial is to investigate the efficacy and tolerance of Ambroxol lozenges 20 mg in the treatment of sore throat in patients with acute viral pharyngitis.

Conditions

Pharyngitis

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline

  The calculation will be based on the pain intensity (PI) assessment by the patient before and then at (pain intensity difference at 30 minutes (PID30)), (pain intensity difference at 60 minutes (PID60)), (pain intensity difference at 120 minutes (PID120)) and (pain intensity difference at 180 minutes (PID180)) after the 1st lozenge. Using the difference in PI from pre-dose baseline for each time point subsequent to dosing, the SPIDnorm will be calculated as SPIDnorm = (30\*PID30 + 30\*PID60 + 60\*PID120 + 60\*PID180)/(180\*PI (baseline)) The patient rates the intensity of his sore throat pain on a 6-point Verbal Rating Scale (VRS) pain intensity (PI) before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain.

  pre-dose baseline and 30, 60, 120, and 180 minutes

Secondary Outcomes (4)

• Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge

  0.5, 1, 2 and 3 hours

• Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge

  pre-dose baseline and 0.5, 1, 2 and 3 hours

• Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation

  Day 1 and Day 2

• Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation

  Day 1 and Day 2

Study Arms (2)

Control

PLACEBO COMPARATOR

Drug: Placebo

Ambroxol

EXPERIMENTAL

Drug: Ambroxol

Interventions

Ambroxol DRUG

Ambroxol

Placebo DRUG

Control

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

1\. Patients having a sore throat with acute viral pharyngitis. 2. Female and male ambulant patients between the ages of 18 and 65. 3. The throat pain intensity is rated at least severe on the VRS (PI). 4. Written Informed Consent is given by the patient. 5. Compliance by the patient seems guaranteed. 1. Patients with symptoms of primarily bacterial pharyngitis or bacterial secondary infection (clinical findings; inter alia assessment of exudate). 2. First indication of symptoms of acute pharyngitis (e.g., sore throat) occurred more than 3 days ago already. 3. Counting of white blood cell in blood routine examination exceeds 10?109/L. 4. Patients who suffered from acute viral or bacterial pharyngitis in the past 4 weeks. 5. Broncho-motor disorders or concomitant diseases with relatively large quantities of secretion (danger of secretion blockage). 6. Known hypersensitivity to Ambroxol or to auxiliary substances contained in the tablet. 7. Previous and/or existing tumour condition. 8. Pregnancy and/or breast-feeding. 9. Alcohol, and/or drug abuse. 10. Simultaneous participation in another clinical trial.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (4)

Boehringer Ingelheim Investigational Site

Nanjing, China

Location

Boehringer Ingelheim Investigational Site

Shanghai, China

Location

ENT Subsidiary of Fudan University Hospital

Shanghai, China

Location

Boehringer Ingelheim Investigational Site

Wuhan, China

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Ambroxol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Bromhexine; Aniline Compounds; Amines; Organic Chemicals; Cyclohexylamines

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim Shanghai

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2007
• First Posted: September 5, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-04

Locations

CN (4)