PharyngitisPhase 4DoriPhaNCT03323528
Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis
A Phase 4 study testing Benzalkonium Chloride-Benzocaine Topical in people with Pharyngitis, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.
Trial summary
The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pharyngitis
- What is being tested?
- Benzalkonium Chloride-Benzocaine Topical
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2017to 15 Nov 2017
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients aged ≥18 years
- Signed informed consent form
- Clinically diagnosed acute pharyngitis (TPA ≥5)
- Recent onset of symptoms (≤24 hours)
- Pain intensity of ≥8 on an 11-point NRS
- Difficulty in swallowing (100-mm VAS ≥50 mm)
Who cannot join
- Patients with strong suspicion of streptococcus A infection (McIsaac score ≥3)
- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- Purulent tonsillitis
- The use of systemic/local antibiotics in the throat area within 7 days prior to screening and during the study
- The use of any systemic analgesics/local analgesics in the throat area (e.g. non-steroidal drugs, [acetylsalicylic acid >100 mg], paracetamol) within 36 hours prior to screening and during the study
- The use of local anaesthetics for treatment of sore throat within 2 days prior to screening and during the study
- The use of any systemic anti-inflammatory drug/local anti-inflammatory drug in the throat area (e.g. glucocorticoids) within 4 weeks prior to screening and during the study
- The use of any other 'sore throat medication' (e.g., lozenges, drops, sprays) or other 'cold medication' that could have interfered with the results of the study within 7 days prior to screening and during the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
doc-HNO for the DoriPha investigators
Röthenbach an der Pegnitz, 90552
About this study
Official title: A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis
The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.
Read the detailed description
In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed.
- Conditions
- Pharyngitis
- Being tested
- Benzalkonium Chloride-Benzocaine Topical, Placebo Oral Tablet
- Keywords
- Dorithricin, Tyrothricin, Benzalkonium chloride, Benzocaine, placebo-controlled, Pharyngitis, sore throat, throat pain, difficulty swallowing, complete responder, lozenge, Non-streptococcal Infections
- Medical subject headings
- Pharyngitis, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzalkonium Chloride-Benzocaine TopicalDrug
Also called triple combination
Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
Placebo Oral TabletDrug
Also called Placebo lozenge
Placebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge.
Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
| Study group | Role | What they receive |
|---|---|---|
| Dorithricin | Active comparator | Dorithricin throat lozenges is a fixed combination of three active substances: Benzalkonium Chloride-Benzocaine Topical plus tyrothricin. Lozenge has to be sucked slowly until it fully dissolves in the mouth and dosed up to 8 lozenges per day. Test product without mint oil.
Intervention: The initial dose is administered at the study site. Patients administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day. Receives: Drug: Benzalkonium Chloride-Benzocaine Topical |
| Placebo | Placebo comparator | Placebo Oral Tablet is taken orally. Placebo consists of a lozenge with matched appearance and the same excipients as those of the Dorithricin lozenge. The initial dose (2 lozenges simultaneously) is administered at the study site.
Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of total responders assessed at Visit 2 (72 hours after first treatment)
complete resolution of throat pain and difficulty in swallowing at Visit 2
Measured: 72 hours after first treatment
Secondary outcomes (3)
percentage of total responders assessed after 48 hours after first treatment
complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment
Measured: 48 hours after first treatment
percentage of patients with complete resolution of throat pain 72 hours after first treatment
complete resolution of throat pain after 72 hours after first treatment
Measured: 72 hours after first treatment
percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment
complete resolution of difficulty in swallowing after 72 hours after first treatment
Measured: 72 hours after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Feb 2017
- Primary completion2 Jul 2017
- Study completion15 Nov 2017
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized allocation of participants to verum or placebo (1:1)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital Muenster
- Responsible party
- Sponsor
- Investigators
- R Ammer, MD, PhD, Study director, MEDICE Arzneimittel Puetter GmbH&Co.KGR Ammer, MD, PhD, Study director, Universtiy hospital Muenster, MedD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323528
- Sponsor's protocol ID
- 2016-003962-24
- Other IDs
- 2016
- Acronym
- DoriPha
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: study protocol, statistical analysis plan, informed consent form, clinical study report are shared with all 26 recruited centers of the DoriPha investigators
Publications
Palm J, Fuchs K, Stammer H, Schumacher-Stimpfl A, Milde J; DoriPha investigators. Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha). Int J Clin Pract. 2018 Dec;72(12):e13272. doi: 10.1111/ijcp.13272. Epub 2018 Oct 17.
PubMed 30329199
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis
- ClinicalTrials.gov ID
- NCT03323528
- Acronym / sponsor ID
- DoriPha / 2016-003962-24
- Conditions
- Pharyngitis
- Keywords
- Dorithricin, Tyrothricin, Benzalkonium chloride, Benzocaine, placebo-controlled, Pharyngitis, sore throat, throat pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Medice Arzneimittel Pütter GmbH & Co KGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital Muenster
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 2 Jul 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 27 Oct 2017 (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.
The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.
Detailed description
In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized allocation of participants to verum or placebo (1:1)
| Arm | Type | Receives |
|---|---|---|
| Dorithricin | Active comparator | Drug: Benzalkonium Chloride-Benzocaine TopicalDorithricin throat lozenges is a fixed combination of three active substances: Benzalkonium Chloride-Benzocaine Topical plus tyrothricin. Lozenge has to be sucked slowly until it fully dissolves in the mouth and dosed up to 8 lozenges per day. Test product without mint oil. Intervention: The initial dose is administered at the study site. Patients administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day. |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletPlacebo Oral Tablet is taken orally. Placebo consists of a lozenge with matched appearance and the same excipients as those of the Dorithricin lozenge. The initial dose (2 lozenges simultaneously) is administered at the study site. Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female outpatients aged ≥18 years
- Signed informed consent form
- Clinically diagnosed acute pharyngitis (TPA ≥5)
- Recent onset of symptoms (≤24 hours)
- Pain intensity of ≥8 on an 11-point NRS
Key exclusion criteria (8 listed)
- Patients with strong suspicion of streptococcus A infection (McIsaac score ≥3)
- Positive rapid streptococcus A test (rapid antigen detection test) to exclude the major bacterial pathogen responsible for sore throat
- Purulent tonsillitis
- The use of systemic/local antibiotics in the throat area within 7 days prior to screening and during the study
- The use of any systemic analgesics/local analgesics in the throat area (e.g. non-steroidal drugs, [acetylsalicylic acid >100 mg], paracetamol) within 36 hours prior to screening and during the study
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 |
|---|---|---|
| Benzalkonium Chloride-Benzocaine TopicalAlso: triple combinationDorithricin = tyrothricin, benzalkonium chloride, benzocaine | Drug | Dorithricin |
| Placebo Oral TabletAlso: Placebo lozengePlacebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge. Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day. | Drug | Placebo |
Primary outcome
percentage of total responders assessed at Visit 2 (72 hours after first treatment)
Time frame: 72 hours after first treatment
complete resolution of throat pain and difficulty in swallowing at Visit 2
3 secondary outcomes
percentage of total responders assessed after 48 hours after first treatment
Time frame: 48 hours after first treatment
percentage of patients with complete resolution of throat pain 72 hours after first treatment
Time frame: 72 hours after first treatment
percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment
Time frame: 72 hours after first treatment
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 28 Nov 2017.
- Derived from this study: PubMed 30329199Palm J, Fuchs K, Stammer H, Schumacher-Stimpfl A, Milde J; DoriPha investigators. Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha). Int J Clin Pract. 2018 Dec;72(12):e13272. doi: 10.1111/ijcp.13272. Epub 2018 Oct 17.
- Test product descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: No. study protocol, statistical analysis plan, informed consent form, clinical study report are shared with all 26 recruited centers of the DoriPha investigators
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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.
R Ammer, MD, PhD study director
MEDICE Arzneimittel Puetter GmbH&Co.KG
R Ammer, MD, PhD study director
Universtiy hospital Muenster, MedD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzalkonium Chloride-Benzocaine Topical in people with Pharyngitis, run by Medice Arzneimittel Pütter GmbH & Co KG at 1 site in Germany.
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 6 inclusion and 8 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 28 Nov 2017. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
percentage of total responders assessed at Visit 2 (72 hours after first treatment) (time frame: 72 hours after first treatment). 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 NCT03323528, 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 28 Nov 2017.