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NCT02630992 · ClinicalTrials.gov registry record · Phase 3
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
A Phase 3 study, sponsored by Nader Shaikh.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT02630992 is a Phase 3 study that has completed, run by Nader Shaikh. The registered enrollment target is 112 participants.
The verdict
NCT02630992, a Phase 3 study, has completed, sponsored by Nader Shaikh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investigators will focus on the proportion of subjects who develop protocol-defined diarrhea and proportion who develop diaper dermatitis that occasions the prescription of antifungal medication.
Interventions
- DRUG Amoxicillin-Clavulanate potassium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02630992
The ClinicalTrials.gov registry entry for NCT02630992 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nader Shaikh, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amoxicillin-Clavulanate potassium is the first listed.
NCT02630992 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02630992 about?
NCT02630992 is a clinical study titled "Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media". To evaluate the safety profile of amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day (formulation 1) or at 80/2.85 mg/kg/day (formulation 2) in two divided doses for 10 days. Investiga...
What is the current status of trial NCT02630992?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2015-12. Estimated completion is 2017-07.
What interventions are being tested in trial NCT02630992?
The interventions under investigation include: Amoxicillin-Clavulanate potassium (DRUG).
Who is sponsoring clinical trial NCT02630992?
This trial is sponsored by Nader Shaikh, which has 3 total clinical trials registered on ClinicalTrials.gov.
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