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NCT01734551 · ClinicalTrials.gov registry record · Phase 4
NAS Treatment - Opiate Versus Non-Opiate
A Phase 4 study, sponsored by Henrietta Bada.
- Completed
- Registry status
- Phase 4
- Development phase
- 31
- Enrollment target
NCT01734551: Completed Phase 4 study, sponsored by Henrietta Bada.
NCT01734551 is a Phase 4 study that has completed, run by Henrietta Bada. The registered enrollment target is 31 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01734551, a Phase 4 study, has completed, sponsored by Henrietta Bada.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is different from morphine. It is also used for babies, and even adults for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if one may be better than the other.
Primary Outcome
Mean of total Finnegan Scores obtained every 3 hours on days 2, 7, and 14 following start of treatment; A score is a number representing the total score or sum from 21 items or symptoms or manifestations of opiate withdrawal in newborn infants. The total score ranges from 0 to 43. Reference: 1. Finnegan LP, Connaughton JF, Jr., Kron RE, et al. Neonatal abstinence syndrome: assessment and management. Addict Dis 1975;2(1-2):141-58. Although normal newborn may manifest mild symptoms that will give
Interventions
- DRUG Morphine
- DRUG Clonidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-12 |
| Phase | Phase 4 |
What the finished NCT01734551 record still lists
NCT01734551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Morphine is the first listed.
NCT01734551 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01734551 about?
NCT01734551 is a clinical study titled "NAS Treatment - Opiate Versus Non-Opiate". The purpose of this study is to compare two different medicines to treat babies with opiate withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine is another drug, but is dif...
What is the current status of trial NCT01734551?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 31 participants. The study started on 2011-09. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01734551?
The interventions under investigation include: Morphine (DRUG), Clonidine (DRUG).
Who is sponsoring clinical trial NCT01734551?
This trial is sponsored by Henrietta Bada, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01734551's enrollment target sits among peer trials
31 1544th of 2000 higher than 449 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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