Trial record 1 of 1 for:
lps15328
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis (DELICIOUS)
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ClinicalTrials.gov Identifier: NCT03583658 |
Recruitment Status :
Completed
First Posted : July 11, 2018
Last Update Posted : April 25, 2022
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
Tracking Information | |||||||
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First Submitted Date ICMJE | June 18, 2018 | ||||||
First Posted Date ICMJE | July 11, 2018 | ||||||
Last Update Posted Date | April 25, 2022 | ||||||
Actual Study Start Date ICMJE | June 30, 2018 | ||||||
Actual Primary Completion Date | September 2, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in pain intensity difference (PID) [ Time Frame: hour 3 ] Change from baseline to hour 3 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-3h)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis | ||||||
Official Title ICMJE | A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis | ||||||
Brief Summary | Primary Objective: To assess the efficacy of the new hard boiled Ambroxol lozenges 20 mg for the relief of sore throat pain in patients with acute pharyngitis. Secondary Objective: To assess the safety of the new hard boiled Ambroxol lozenges 20 mg in patients with acute pharyngitis. |
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Detailed Description | Duration per participant is up to 4 days. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Pharyngitis | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Sousa R, Lakha DR, Brette S, Hitier S. A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Ambroxol Hard-Boiled Lozenges in Patients with Acute Pharyngitis. Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
390 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | September 2, 2018 | ||||||
Actual Primary Completion Date | September 2, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria: Patients suffering from pharyngitis of bacterial origin. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (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 | South Africa | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03583658 | ||||||
Other Study ID Numbers ICMJE | LPS15328 U1111-1202-9392 ( Other Identifier: UTN ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Sanofi | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Sanofi | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Sanofi | ||||||
Verification Date | April 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |