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NCT01530009 · ClinicalTrials.gov registry record · NA
The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children
A NA study, sponsored by Nationwide Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT01530009: Completed NA study, sponsored by Nationwide Children's Hospital.
NCT01530009 is a NA study that has completed, run by Nationwide Children's Hospital. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01530009, a NA study, has completed, sponsored by Nationwide Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable effect on upper gastrointestinal motility compared to placebo. In particular, induction of phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary outcome of the study. MMCs are periodic waves of electrical activity resulting in muscular contractions that pass through the walls of the stomach and intestinal tract during the fasting state. It is characterized by an initial period where there is a minimal electrical activity and muscular contraction (phase I), followed by a gradual increase in the frequency of contractions (phase III) that often leads to a characteristic cluster of contractions (phase III). This cycle occurs only in the fasting state in normal individuals and the frequency of phase III is quite varied, dependent on age and the presence of any underlying abnormalities in gastrointestinal motility. Secondary outcomes will include characteristics of the MMC, patient demographics in responders and non-responders, and the safety profile of AMX at the intervention dose.
Primary Outcome
The migrating motor complex passes through the GI tract during fasting. It is initially characterized by minimal electrical activity and muscular contraction (phase I), followed by an increase in the frequency of contractions (phase III) and finally a characteristic cluster of contractions (phase III). This cycle occurs only in the fasting state in normal individuals and the frequency of phase III depends on age and the presence of any underlying gastrointestinal dysmotility. The primary outcome
Interventions
- OTHER Placebo
- DRUG Amoxicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2012-01 |
| Est. Completion | 2022-01 |
| Phase | NA |
What the finished NCT01530009 record still lists
NCT01530009 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01530009 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01530009 about?
NCT01530009 is a clinical study titled "The Effect of Amoxicillin Versus Placebo on Gastrointestinal Motility in Children". The goal of this study is to determine whether amoxicillin (AMX) alone has an appreciable effect on upper gastrointestinal motility compared to placebo. In particular, induction of phase III of the interdigestive migrating motor complex (MMC) by AMX will be the primary outcome of the study. MMCs are...
What is the current status of trial NCT01530009?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2012-01. Estimated completion is 2022-01.
What interventions are being tested in trial NCT01530009?
The interventions under investigation include: Placebo (OTHER), Amoxicillin (DRUG).
Who is sponsoring clinical trial NCT01530009?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01530009's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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