TerminatedPhase 4

Evaluation of Inflammatory Symptoms Reduction With Amoxicillin + Ketoprofen in Acute Pharyngeal Tonsillitis in Pediatric Patients

Stopped: Recruitment challenges despite several attenpts to increase enrollment

Brazil106 participantsStarted 2008-11

Plain-language 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.

Who can participate

Age range

4 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with reduction of inflammatory signs and symptoms after 24 hours of treatment

Timeframe: 24 hours

Trial details

NCT IDNCT00799838

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-06

View on ClinicalTrials.gov More Pharyngotonsillitis trials

Who can participate

Age range

4 Years – 11 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.