PharyngotonsillitisPhase 4DROPSNCT00799838
Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients
A Phase 4 study testing Ketoprofen and Amoxicillin in people with Pharyngotonsillitis, run by Sanofi at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin. Read more about this study
- Who is it for?
- Ages 4 to 11 years
- Conditions the study is for
- Pharyngotonsillitis
- What is being tested?
- Ketoprofen and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Jun 2013
- 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 4 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Quick-test positive for Streptococcus pyogenes;
- Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation;
- Pain (for swallowing) evaluated by Wong Baker Faces Pain scale with at least grade 3;
- Presence of at least two of the follow symptoms:
- Hyperemia and edema evaluated with at least 2 out of 4 crosses
- Fever in the previous 48 hours
- Cervical adenomegaly
- Tonsilla with erythema or erythema and white exsudate.
Who cannot join
- History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions;
- History and laboratorial confirmation of hematologic, hepatic or renal disorders;
- Use of nonsteroidal antiinflammatory drugs (NSAID) during the last 3 weeks and gastroesophageal reflux during the last 6 months;
- Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours;
- History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen.
- 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: Local, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen and Amoxicillin in Pediatric Patients.
The purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.
Read the detailed description
The total duration of the study period per patient is 10 ± 1 day
- Conditions
- Pharyngotonsillitis
- Being tested
- Ketoprofen, Placebo (for Ketoprofen), Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetoprofenDrug
Formulation: oral solution 20mg/mL
Route of administration: oral
Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d
Placebo (for Ketoprofen)Drug
Formulation: oral solution
Route of administration: oral
Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d
AmoxicillinDrug
Formulation: suspension 125mg/5 mL
Route of administration: oral
Dose regimen: 20-40mg/Kg/day administered t.i.d
| Study group | Role | What they receive |
|---|---|---|
| Ketoprofen + Amoxicillin | Experimental | Ketoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days Receives: Drug: Ketoprofen; Drug: Amoxicillin |
| Amoxicillin | Placebo comparator | Placebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days Receives: Drug: Placebo (for Ketoprofen); Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
Measured: 24 hours
Secondary outcomes (3)
Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment
Measured: 72 hours
Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication
Measured: 24 hours and 72 hours
Number of patients who used rescue medication after randomization.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Recruitment challenges despite several attenpts to increase enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharyngotonsillitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaderson Lima, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799838
- Sponsor's protocol ID
- KETOP_L_03102
- Other IDs
- 2014-004002-15, 2014
- Acronym
- DROPS
- Status last verified
- Mar 2014
- First submitted
- 28 Nov 2008
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local, Phase IV, Multicenter, Double-blind, Randomized, Parallel, With Two Treatment Arms, Placebo-controlled Study to Evaluate the Reduction of Inflammatory Symptoms in the Treatment of Bacterial Pharyngitis With Ketoprofen and Amoxicillin in Pediatric Patients.
- ClinicalTrials.gov ID
- NCT00799838
- Acronym / sponsor ID
- DROPS / KETOP_L_03102
- Conditions
- Pharyngotonsillitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges despite several attenpts to increase enrollment
- Enrolment
- 106 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Dec 2008 (estimated)
- 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 purpose of this study is to evaluate the inflammatory symptoms and signs (hyperemia, edema and pain) reduction after 24 hours of treatment with ketoprofen drops when associated to amoxicillin.
Detailed description
The total duration of the study period per patient is 10 ± 1 day
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketoprofen + Amoxicillin | Experimental | Drug: Ketoprofen, Drug: AmoxicillinKetoprofen + Amoxicillin for 3 days, then Amoxicillin alone for 7 days |
| Amoxicillin | Placebo comparator | Drug: Placebo (for Ketoprofen), Drug: AmoxicillinPlacebo (for ketoprofen) + Amoxicillin for 3 days, then Amoxicillin alone for 7 days |
Who may qualify
- Ages
- 4 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Quick-test positive for Streptococcus pyogenes;
- Indication for treatment with amoxicillin according to labeling and physician's clinical evaluation;
- Pain (for swallowing) evaluated by Wong Baker Faces Pain scale with at least grade 3;
- Presence of at least two of the follow symptoms:
Key exclusion criteria (6 listed)
- History of cardiovascular, gastrointestinal, metabolic or psychiatric conditions;
- History and laboratorial confirmation of hematologic, hepatic or renal disorders;
- Use of nonsteroidal antiinflammatory drugs (NSAID) during the last 3 weeks and gastroesophageal reflux during the last 6 months;
- Use of analgesic or anti inflammatory medication (except Paracetamol) in the previous 12 hours;
- History of allergy or hypersensitivity to amoxicillin and/ or ketoprofen.
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 |
|---|---|---|
| KetoprofenFormulation: oral solution 20mg/mL Route of administration: oral Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d | Drug | Ketoprofen + Amoxicillin |
| Placebo (for Ketoprofen)Formulation: oral solution Route of administration: oral Dose regimen: 1 drop/Kg for children aged between 4 to 6 years old or 25 drops for children from 7 to 11 years old administered t.i.d | Drug | Amoxicillin |
| AmoxicillinFormulation: suspension 125mg/5 mL Route of administration: oral Dose regimen: 20-40mg/Kg/day administered t.i.d | Drug | Amoxicillin, Ketoprofen + Amoxicillin |
Primary outcome
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment
Time frame: 24 hours
3 secondary outcomes
Number of patients with reduction of inflammatory signs and symptoms after 72 hours of treatment
Time frame: 72 hours
Number of patients with reduction of inflammatory signs and symptoms with no use of rescue medication
Time frame: 24 hours and 72 hours
Number of patients who used rescue medication after randomization.
Time frame: 72 hours
Results and safety
The study was stopped early (reason given: Recruitment challenges despite several attenpts to increase enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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.
Jaderson Lima, MD 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 4 study testing Ketoprofen and Amoxicillin in people with Pharyngotonsillitis, run by Sanofi at 1 site in Brazil.
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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 24 Oct 2014. 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 Brazil. 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 was stopped early (reason given: Recruitment challenges despite several attenpts to increase enrollment). Results are not available in the source record.
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?
Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2014.