PharyngitisPhase 3DELICIOUSNCT03583658
Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis
A Phase 3 study testing ambroxol BIH1526 in people with Pharyngitis, run by Sanofi at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharyngitis
- What is being tested?
- ambroxol BIH1526
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 390 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 Jun 2018to 2 Sep 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.
- Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.
- Signed written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Duration per participant is up to 4 days.
- Conditions
- Pharyngitis
- Being tested
- ambroxol BIH1526, placebo
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ambroxol BIH1526Drug
Pharmaceutical form: lozenges Route of administration: oromucosal
placeboDrug
Pharmaceutical form: lozenges Route of administration: oromucosal
| Study group | Role | What they receive |
|---|---|---|
| Ambroxol hydrochloride (BIH1526) | Active comparator | One lozenge 20 mg on as-needed basis, up to 6 times per day Receives: Drug: ambroxol BIH1526 |
| Placebo | Placebo comparator | One lozenge on as-needed basis, up to 6 times per day Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity difference (PID)
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)
Measured: hour 3
Secondary outcomes (6)
Change in SPID
Change from baseline to hour 24 in time-weighted average of PID after the first lozenge, expressed as the ratio of the predose baseline, sum of PID (SPIDnorm, 0-24h)
Measured: hour 24
3-hour patient assessment of efficacy
Patient assessment of efficacy after 3 hours of the first study drug intake using a 5-point verbal rating scale (VRS) to rate whether the trial medication relieves sore throat pain, where 0 = poor and 4 = excellent
Measured: hour 3
24-hour patient assessment of efficacy
Patient assessment of efficacy after 24 hours of the first study drug intake using a 5-point VRS
Measured: hour 24
Adverse events
Incidence of the adverse events
Measured: baseline to day 4
Patient assessment of tolerability
Patient assessment of tolerability after 3 hours, Day 1, on Day 2, Day 3 and Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent
Measured: hour 3, hour 24 and day 2, day 3 or day 4
Final assessment of tolerability
Investigator and patient assessment of tolerability on Day 4 using a 5-point VRS, where 0 = poor and 4 = excellent
Measured: day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start30 Jun 2018
- Primary completion2 Sep 2018
- Study completion2 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharyngitisStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03583658
- Sponsor's protocol ID
- LPS15328
- Other IDs
- U1111-1202-9392
- Acronym
- DELICIOUS
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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.
PubMed 32026411
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03583658
- Acronym / sponsor ID
- DELICIOUS / LPS15328
- Conditions
- Pharyngitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 2 Sep 2018 (actual)
- Study completion
- 2 Sep 2018 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Duration per participant is up to 4 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambroxol hydrochloride (BIH1526) | Active comparator | Drug: ambroxol BIH1526One lozenge 20 mg on as-needed basis, up to 6 times per day |
| Placebo | Placebo comparator | Drug: placeboOne lozenge on as-needed basis, up to 6 times per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult male or female patients complaining of sore throat due to acute pharyngitis with an onset no more than 72 hours prior to Visit 1.
- Patients with a score of 6 or greater on a 0-10-point pain intensity numerical rating scale.
- Signed written informed consent.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ambroxol BIH1526Pharmaceutical form: lozenges Route of administration: oromucosal | Drug | Ambroxol hydrochloride (BIH1526) |
| placeboPharmaceutical form: lozenges Route of administration: oromucosal | Drug | Placebo |
Primary outcome
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)
6 secondary outcomes
Change in SPID
Time frame: hour 24
3-hour patient assessment of efficacy
Time frame: hour 3
24-hour patient assessment of efficacy
Time frame: hour 24
Adverse events
Time frame: baseline to day 4
Patient assessment of tolerability
Time frame: hour 3, hour 24 and day 2, day 3 or day 4
Final assessment of tolerability
Time frame: day 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Derived from this study: PubMed 32026411Sousa 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.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ambroxol BIH1526 in people with Pharyngitis, run by Sanofi at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity difference (PID) (time frame: hour 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03583658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.