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NCT01723722 · ClinicalTrials.gov registry record · Phase 4

Treatment of Neonatal Abstinence Syndrome

A Phase 4 study of Neonatal Abstinence Syndrome, sponsored by Eastern Maine Medical Center.

Completed
Registry status
Phase 4
Development phase
40
Enrollment target
1
Study location

NCT01723722 is a Phase 4 study of Neonatal Abstinence Syndrome that has completed, run by Eastern Maine Medical Center. The registered enrollment target is 40 participants, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01723722, a Phase 4 study of Neonatal Abstinence Syndrome, has completed, sponsored by Eastern Maine Medical Center.

COMPLETED
Registry status
Phase 4
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbital is the initial drug used to stabilize neonatal withdrawal.

Interventions

  • DRUG Methadone
  • DRUG Diluted Deodorized Tincture of Opium

Study Locations (1)

Maine

  • Eastern Maine Medical Center - Bangor

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2007-01
Est. Completion 2009-09
Phase Phase 4

Sponsor

Eastern Maine Medical Center

3 total trials

What the Registry Record Tells You About NCT01723722

The ClinicalTrials.gov registry entry for NCT01723722 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 64-participant average among 17 other Neonatal Abstinence Syndrome trials with a reported enrollment target (37% lower). The listed sponsor is Eastern Maine Medical Center, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neonatal Abstinence Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Methadone is the first listed.

NCT01723722 reports 1 study location spanning 1 distinct geographic area - top geographies include Maine.

Frequently Asked Questions

What is clinical trial NCT01723722 about?

NCT01723722 is a clinical study titled "Treatment of Neonatal Abstinence Syndrome". This study compares treatment of Neonatal Abstinence Syndrome (NAS) with two different drugs for the difference in the length of treatment. This is a randomized, open-label comparison of phenobarbital and methadone versus phenobarbital and diluted deodorized tincture of opium (dDTO) where phenobarbi...

What is the current status of trial NCT01723722?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2007-01. Estimated completion is 2009-09.

What conditions does trial NCT01723722 study?

This clinical trial studies the following conditions: Neonatal Abstinence Syndrome.

What interventions are being tested in trial NCT01723722?

The interventions under investigation include: Methadone (DRUG), Diluted Deodorized Tincture of Opium (DRUG).

Who is sponsoring clinical trial NCT01723722?

This trial is sponsored by Eastern Maine Medical Center, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01723722 being conducted?

This trial has 1 study location across Maine. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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