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

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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

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.

Condition or disease Intervention/treatment Phase
Pharyngitis Drug: Ambroxol Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Patients With Acute Viral Pharyngitis
Actual Study Start Date : August 1, 2007
Actual Primary Completion Date : January 1, 2008
Actual Study Completion Date : January 1, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Arm Intervention/treatment
Placebo Comparator: Control Drug: Placebo
Experimental: Ambroxol Drug: Ambroxol



Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525044


Locations
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China
Boehringer Ingelheim Investigational Site
Nanjing, China
Boehringer Ingelheim Investigational Site
Shanghai, China
ENT Subsidiary of Fudan University Hospital
Shanghai, China
Boehringer Ingelheim Investigational Site
Wuhan, China
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim Shanghai
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00525044    
Other Study ID Numbers: 18.490
First Posted: September 5, 2007    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ambroxol
Expectorants
Respiratory System Agents