Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)
NCT01406275 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 363
Last updated 2017-05-16
Summary
This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media.
("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)
Conditions
- Otitis Maedia
Interventions
- DRUG
-
Amoxicillin and clavulanate
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Eligibility
- Max Age
- 14 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-01-31
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
More Related Trials
-
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
NCT01511107 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
NCT04600752 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children
NCT06895135 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
NCT00147914 ·Status: COMPLETED ·Phase: PHASE4
-
Acute Otitis Media (AOM) Therapy Trial in Young Children
NCT00377260 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Assess the Efficacy and Safety of Potassium Clavulanate/Amoxicillin in Children With Acute Bacterial Rhinosinusitis
NCT01934231 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
NCT00644943 ·Status: COMPLETED ·Phase: PHASE4
-
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
NCT00051753 ·Status: COMPLETED ·Phase: PHASE3
-
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia
NCT00638859 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetics of Sulopenem in Adolescents
NCT04700787 ·Status: WITHDRAWN ·Phase: PHASE1
-
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
NCT00644553 ·Status: COMPLETED ·Phase: PHASE3
-
To Investigate PK and PD of CJ-12420, Clarithromycin, Amoxicillin After Multiple Dose Administration
NCT03011996 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Single Dose Intravenous Moxifloxacin in Pediatric Patients
NCT01049022 ·Status: COMPLETED ·Phase: PHASE1
-
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
NCT04016051 ·Status: COMPLETED ·Phase: PHASE3
-
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
NCT00638534 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
NCT01204385 ·Status: COMPLETED
-
Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
NCT02380352 ·Status: COMPLETED ·Phase: PHASE4
-
Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
NCT02891915 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
NCT00354965 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
NCT04215991 ·Status: COMPLETED ·Phase: PHASE2
-
A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection
NCT05584683 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study of Balsamic Bactrim in Pediatric Participants With Acute Bronchitis
NCT02879981 ·Status: COMPLETED
-
Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications
NCT00644891 ·Status: COMPLETED ·Phase: PHASE4
-
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
NCT02935374 ·Status: COMPLETED ·Phase: PHASE4
-
Levofloxacin in Bacterial Rhinosinussitis
NCT02712502 ·Status: COMPLETED