Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525044
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE September 3, 2007
First Posted Date  ICMJE September 5, 2007
Results First Submitted Date  ICMJE December 20, 2018
Results First Posted Date  ICMJE July 11, 2019
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE August 1, 2007
Actual Primary Completion Date January 1, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
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 [ Time Frame: pre-dose baseline and 30, 60, 120, and 180 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 3, 2007)
Indication of pain on the VRS(verbal rating scale) in the first 3 hours (the patient rates his/her pain on a six point verbal rating scale).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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 [ Time Frame: 0.5, 1, 2 and 3 hours ]
    Pain intensity (PI) 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. The patient rates the intensity of his sore throat condition on a 6-point rating scale [VRS(PI)-verbal rating scale (pain intensity)] 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. Adjusted Mean (Standard Error) are presented for this outcome measure.
  • 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 [ Time Frame: pre-dose baseline and 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. Adjusted Mean (Standard Error) are presented for this outcome measure.
  • 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 [ Time Frame: Day 1 and Day 2 ]
    Assessment of redness of the pharyngeal mucosa by the investigator on a 5-point VRS (normal, slightly red, clearly red, very red, severe inflammation) at pre-dose baseline and at the end-of-study evaluation.
  • Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation [ Time Frame: Day 1 and Day 2 ]
    Assessment of Patients' Assessment of Effectiveness on a 5-point VRS ("very good", "good", "neither good nor poor", "not very good", "not at all good") at pre-dose baseline and at the end-of-study evaluation
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2007)
patient assesses the effectiveness and the tolerance Participating doctor?s assessment of tolerance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Double-blind Trial to Investigate Efficacy and Tolerance of Ambroxol Lozenges 20 mg in Sore Throat
Official Title  ICMJE Double-blind, Randomized, Placebo-controlled Trial to Investigate the Efficacy and Tolerance of Ambroxol Lozenges 20 mg in the Treatment of Sore Throat in Patients With Acute Viral Pharyngitis
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.
Detailed Description

Male and female ambulant patients complaining of a sore throat caused by acute viral pharyngitis. Every patient may be included in the trial only once. A total of 250 male and female ambulant patients between the ages of 18 and 65 years will be enrolled. Approximately 8 centers will be recruited each enrolling approximately 30-32 patients.

Study Hypothesis:

The two-sided test hypothesis, that the results of the active treatment group with 20 mg Ambroxol and the placebo group do not differ with regard to the primary endpoint (null hypothesis (H0) will be tested against the alternative (H1) that they are not equal.

Comparison(s):

PRIMARY ENDPOINT:

Indication of pain on the VRS (PI)-verbal rating scale (pain intensity)-in the first 3 hours (the patient rates his/her pain on a six-point verbal rating scale).

SECONDARY ENDPOINT (S):

  1. Patient's assessment of effectiveness and tolerance. The patient assesses the effectiveness and the tolerance of the test medicine for treating his sore throat at the end of the first and second day of treatment, by means of a verbal rating scale.
  2. Participating doctors assessment of tolerance.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pharyngitis
Intervention  ICMJE
  • Drug: Ambroxol
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Control
    Intervention: Drug: Placebo
  • Experimental: Ambroxol
    Intervention: Drug: Ambroxol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2013)
249
Original Enrollment  ICMJE
 (submitted: September 3, 2007)
250
Actual Study Completion Date  ICMJE January 1, 2008
Actual Primary Completion Date January 1, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525044
Other Study ID Numbers  ICMJE 18.490
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
PRS Account Boehringer Ingelheim
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP