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NCT00404768 · ClinicalTrials.gov registry record · Phase 2
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
A Phase 2 study of Obstetric Labour, Premature, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT00404768 is a Phase 2 study of Obstetric Labour, Premature that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants. The trial reports 20 study locations across 14 states.
The verdict
NCT00404768, a Phase 2 study of Obstetric Labour, Premature, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxytocin, and therefore pause or prevent contractions. In this study, patients with preterm labor will be given an intravenous infusion of GSK221149A over approximately 12 hours followed by an oral tablet in Parts A and B. In part C of this study, patients with preterm labor will be give an intravenous infusion of GSK221149A over approximately 48 hours. The use of a rescue tocolytic is allowed in the study.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GSK221149A
Study Locations (20)
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tucson
California
- GSK Investigational Site - Colton
- GSK Investigational Site - Loma Linda
- GSK Investigational Site - Los Angeles
North Carolina
- GSK Investigational Site - Chapel Hill
- GSK Investigational Site - Southern Pines
- GSK Investigational Site - Winston-Salem
Alabama
- GSK Investigational Site - Mobile
Arkansas
- GSK Investigational Site - Jonesboro
Delaware
- GSK Investigational Site - Newark
Idaho
- GSK Investigational Site - Idaho Falls
Kansas
- GSK Investigational Site - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2007-10-12 |
| Est. Completion | 2011-07-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00404768
The ClinicalTrials.gov registry entry for NCT00404768 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 93 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obstetric Labour, Premature appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00404768 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Arizona, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00404768 about?
NCT00404768 is a clinical study titled "The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor". Pre-Term Labor (prior to 37 weeks gestation) is the largest single cause of infant morbidity and mortality and is frequently associated with long-term disability. Oxytocin is a hormone produced by the body during labor. GSK221149A is an experimental drug that will be used to block the effects of oxy...
What is the current status of trial NCT00404768?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2007-10-12. Estimated completion is 2011-07-07.
What conditions does trial NCT00404768 study?
This clinical trial studies the following conditions: Obstetric Labour, Premature.
What interventions are being tested in trial NCT00404768?
The interventions under investigation include: Placebo (DRUG), GSK221149A (DRUG).
Who is sponsoring clinical trial NCT00404768?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00404768 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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