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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: Completed Phase 2 study of Obstetric Labour, Premature, sponsored by GlaxoSmithKline.
NCT00404768 is a Phase 2 study of Obstetric Labour, Premature that has completed, run by GlaxoSmithKline. The registered enrollment target is 93 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Vital signs included blood pressure (systolic and diastolic) and heart rate. Maternal blood pressure and heart rate were measured with the participant in the semi-supine position. Blood pressure was measured in millimeters of mercury (mmHg) and heart rate in beats per minute (bpm). Potential clinical concern range for systolic blood pressure: \<85 and \>160 mmHg, for diastolic: \<45 and \>100 mmHg and heart rate: \<40 and \>110 bpm. Only those parameters for which at least one value of potential
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 |
What the finished NCT00404768 record still lists
NCT00404768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (30% lower).
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 names 20 study sites across 14 states, led by 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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Where NCT00404768's enrollment target sits among peer trials
93 766th of 2000 higher than 1,234 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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