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The Safety, Tolerability And ...

The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor

Last Updated: 2018-01-16

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-12

Study Completion Date

2011-07-07

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Obstetric Labour, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Treatment

GSK221149A

Group Type EXPERIMENTAL

GSK221149A

Intervention Type DRUG

6mg/h and 12 mg/h

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matched Placebo to Drug

Interventions

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GSK221149A

6mg/h and 12 mg/h

Intervention Type DRUG

Placebo

Matched Placebo to Drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy pregnant females, 30 -36 weeks pregnant, without ruptured membranes
* 18-45 inclusive
* Symptoms of pre-term labor, (greater than or equal to 6 uterine contractions per hour, each of which at least 30 sec in duration, with cervical dilatation of less than or equal to 4 cm, (measured by tocodynamometry).

Exclusion Criteria

* Any clinically relevant abnormality identified on the screening examination or any other medical condition or circumstance making the patient (mother and/or fetus) unsuitable for participation in the study
* Any clinically relevant pre-existing or pregnancy-related co-morbid condition that may affect maternal pregnancy outcome or neonatal outcome (eg. hypertension, diabetes mellitus, bleeding/clotting diathesis)

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Jonesboro, Arkansas, United States

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Colton, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Newark, Delaware, United States

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Idaho Falls, Idaho, United States

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Kansas City, Kansas, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Newark, New Jersey, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Southern Pines, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Bogotá, , Colombia

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Clamart, , France

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Lille, , France

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Paris, , France

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Poissy, , France

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Suresnes, , France

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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San Juan, , Puerto Rico

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Singapore, , Singapore

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barakaldo (Vizcaya), , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Valencia, , Spain

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Warwick, Warwickshire, United Kingdom

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Coventry, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Countries

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United States Argentina Bulgaria Colombia France Lithuania Puerto Rico Singapore South Korea Spain United Kingdom

References

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Jerry Snidow, Hugh Miller, Guillermo Valenzuela, Steve Thornton, Brendt Stier, Linda Clayton, Michael Fossler, Timothy Montague, Kathleen Beach, Pauline Williams. A Multicenter, Randomized, Double-blind Placebo-controlled Phase II Trial of Retosiban, a Selective Oxytocin Receptor Antagonist, for the Management of Preterm Labor. Am J Obstet Gynecol. 2013;2:S155.

Reference Type BACKGROUND

Thornton S, Valenzuela G, Baidoo C, Fossler MJ, Montague TH, Clayton L, Powell M, Snidow J, Stier B, Soergel D. Treatment of spontaneous preterm labour with retosiban: a phase II pilot dose-ranging study. Br J Clin Pharmacol. 2017 Oct;83(10):2283-2291. doi: 10.1111/bcp.13336. Epub 2017 Jul 11.

Reference Type BACKGROUND

PMID: 28556962 (View on PubMed)

Thornton S, Miller H, Valenzuela G, Snidow J, Stier B, Fossler MJ, Montague TH, Powell M, Beach KJ. Treatment of spontaneous preterm labour with retosiban: a phase 2 proof-of-concept study. Br J Clin Pharmacol. 2015 Oct;80(4):740-9. doi: 10.1111/bcp.12646. Epub 2015 Jun 1.

Reference Type BACKGROUND

PMID: 25819462 (View on PubMed)

Study Documents

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