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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00404768 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Premature Labor |
Drug: Placebo Drug: GSK221149A |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
| Estimated Enrollment: | 75 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo: Placebo Comparator
Placebo
|
Drug: Placebo
Matched Placebo to Drug
|
|
Treatment: Experimental
GSK221149A
|
Drug: GSK221149A
6mg/h and 12 mg/h
|
A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A administered orally to healthy, pregnant females with uncomplicated pre-term labor between 300/7 and 356/7 weeks' gestation
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Show 48 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | OTA105256 |
| Study First Received: | November 27, 2006 |
| Last Updated: | March 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00404768 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Pre Term Labor intravenous fetal fibronectin |
|
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications |