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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: Completed Phase 3 study, sponsored by Nader Shaikh.
NCT02630992 is a Phase 3 study that has completed, run by Nader Shaikh. The registered enrollment target is 112 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants receiving formulation 1 were administered 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 in two divided doses for 10 days. Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product.
Interventions
- DRUG Amoxicillin-Clavulanate potassium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2015-12 |
| Est. Completion | 2017-07 |
| Phase | Phase 3 |
What the finished NCT02630992 record still lists
NCT02630992 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Amoxicillin-Clavulanate potassium is the first listed.
NCT02630992 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02630992's enrollment target sits among peer trials
112 1652nd of 2000 higher than 346 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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