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

Primary Purpose

Obstetric Labour, Premature

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

GSK221149A

Placebo

About this trial

This is an interventional treatment trial for Obstetric Labour, Premature focused on measuring Premature Labor, Pre Term Labor, intravenous, fetal fibronectin

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

GSK221149A

Placebo

Outcomes

Primary Outcome Measures

Number of Participants With Vital Sign Values of Potential Clinical Concern

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 clinical concern was reported are summarized. Number of participants with vital sign values of potential clinical concern are presented.

Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern

All scheduled 12-lead ECGs were obtained after the participant was rested in the semi-supine position for approximately 15 minutes. Whenever 12-lead ECGs were performed at the same nominal time as a blood draw or blood pressure and pulse rate measurement, the 12-lead ECG were obtained first. ECGs were repeated or recorded in triplicate and the average value recorded at the investigators discretion. The potential clinical concern range for ECG parameters were: Absolute QT corrected (QTc) interval: >450 milliseconds (msec), Increase from Baseline (Day 0): QTc >60 msec, PR interval: <110 and >220 msec and QRS interval: <75 and >110 msec. All 12-lead ECGs obtained throughout the study day were evaluated for safety and were reviewed by the investigator or investigator designee. Number of participants with electrocardiogram values of potential clinical concern are presented.

Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical Concern

Hematology parameters included complete blood count with red blood cell indices and white blood cell differential, platelet count, human immune deficiency virus, Hepatitis C antibody and Hepatitis B surface antigen. Clinical chemistry parameters included blood urea nitrogen (BUN), creatinine, glucose, sodium, potassium, phosphate, chloride, total CO2, calcium, aspartate amino transferase (AST), alanine amino transferase (ALT), gamma glutamyltransferase (GGT), alkaline phosphatase, total bilirubin, uric acid, albumin and total protein. Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry and hematology parameter values of potential clinical concern are presented.

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect. Any SAEs assessed as related to study participation (e.g. study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK product was recorded from the time a participant consents to participate in the study up to and including any follow-up contact.

Assessment of Amniotic Fluid Index (AFI)

AFI is a quantitative estimate of amniotic fluid and an indicator of fetal well-being. AFI is the score (expressed in centimetes) given to the amount of amniotic fluid seen on ultrasonography of a pregnant uterus. An AFI between 8 to 18 is considered normal. An AFI < 5 to 6 is considered as oligohydramnios characterized by deficiency of amniotic fluid. An AFI > 18 to 24 is considered as polyhydramnios characterized by excess of amniotic fluid in the amniotic sac.

Number of Participants With 50% Reduction in Uterine Contractions Per Hour in Part A and B

For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose.The number of participants that achieve a reduction of at least 50% in uterine contractions with no cervical change within 6 hours and to maintain that reduction until 12 hours of therapy has been presented.

Fetal Heart Rate Monitoring up to 48 Hours

Fetal heart rate monitoring was incorporated to assess fetal tolerability. Fetal heart rate was monitored continuously at 2, 4, 6, 8, 12, 18, 24, 36 and up to 48 hours post-therapy. Mean fetal heart rate is presented. Data for only key-time points values have been presented.

Number of Participants Achieving Uterine Quiescence

Uterine quiescence was defined as 4 contractions per/hour or less with no cervical change within the first 6 hours of therapy. Number of participants (from part A,B,C) achieving uterine Quiescence are presented.

Secondary Outcome Measures

Number of Participants With Preterm Births in Part C

Preterm is defined as babies born alive before 37 weeks of pregnancy are completed. There are sub-categories of preterm birth, based on gestational age: extremely preterm (<28 weeks) very preterm (28 to <32 weeks). Number of participants with preterm births are presented.

Neonatal Apgar Scores in Part A and B

APGAR scores range from 0 to 2 for each condition (color, reflex response, muscle tone, respiration and heart rate) with a maximum final total score of 10. For heart rate: 0=no heart rate, 1=<100 bpm (baby not very responsive), 2=>100 bpm (baby vigorous); for respiration: 0=no breathing, 1= weak cry, 2=good, strong cry; for muscle tone: 0=limp, 1=some flexing of arms and legs, 2=active motion; for reflex response: 0=no response, grimace during stimulation, 2=grimace and cough or sneeze during stimulation; for color: 0=blue/pale, 1=good body color but blue hands and feet, 3=completely pink or good color. APGAR total score is the sum of sub-scores ranging from 0 to 10, where lower score indicates worst condition and higher score indicates best condition.

Neonatal Weight Gain in Part A and B

Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.

Neonatal Head Circumference in Part A and B

Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.

Neonatal Length Measured at 4-6 Weeks of Age in Part A and B

Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (approximately 4 to 6 weeks of age). Mean Neonatal length is presented.

Derived Plasma GSK221149 Pharmacokinetic Parameters- Area Under Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) and Area Under Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC [0 to Last])

Blood samples (approximately 2mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.

Derived Plasma GSK221149 Pharmacokinetic Parameters- Observed Elimination Half-life (T-half) and Time to Maximum Observed Drug Concentration (T-max)

Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.

Derived Plasma GSK221149 Pharmacokinetic Parameters- Maximum Plasma Concentration (Cmax)

Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.

Neonatal Apgar Scores (at Birth) Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Neonatal Weight Gain Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.

Neonatal Head Circumference Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.

Neonatal Length Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (Week 12). Mean neonatal length is presented.

Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C

Tocolytics are medications used to suppress premature labor. They are given when delivery would result in premature birth. Number of participants who remained undelivered without rescue tocolytic therapy after 48 hours are presented.

Percentage Reduction From Baseline in Number of Uterine Contractions [>30 Sec] Per Hour Within First 6 Hours of Therapy in Part C

For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose. Baseline was Day 0. Reduction from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percentage reduction from Baseline in number of uterine contractions [>30 sec] per hour within first 6 hours of therapy are presented.

Full Information

NCT ID

NCT00404768

First Posted

November 27, 2006

Last Updated

December 18, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00404768

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

October 12, 2007 (Actual)

Primary Completion Date

July 7, 2011 (Actual)

Study Completion Date

July 7, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstetric Labour, Premature

Keywords

Premature Labor, Pre Term Labor, intravenous, fetal fibronectin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

GSK221149A

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

GSK221149A

Intervention Description

6mg/h and 12 mg/h

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matched Placebo to Drug

Primary Outcome Measure Information:

Title

Number of Participants With Vital Sign Values of Potential Clinical Concern

Description

Time Frame

Up to Follow-up (Week 12)

Title

Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern

Description

Time Frame

Up to Follow-up (Week 12)

Title

Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical Concern

Description

Time Frame

Up to 24 hours post-treatment

Title

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Description

Time Frame

Up to Follow-up (Week 12)

Title

Assessment of Amniotic Fluid Index (AFI)

Description

Time Frame

Up to 48 hours-post dose

Title

Number of Participants With 50% Reduction in Uterine Contractions Per Hour in Part A and B

Description

Time Frame

Up to 48 hours post-dose

Title

Fetal Heart Rate Monitoring up to 48 Hours

Description

Time Frame

Up to 48 hours post-dose

Title

Number of Participants Achieving Uterine Quiescence

Description

Time Frame

Up to 48 hours post-dose

Secondary Outcome Measure Information:

Title

Number of Participants With Preterm Births in Part C

Description

Time Frame

Up to 48 hours post-dose

Title

Neonatal Apgar Scores in Part A and B

Description

Time Frame

1 minute and 5 minutes after birth

Title

Neonatal Weight Gain in Part A and B

Description

Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.

Time Frame

At birth and Follow-up (Week 12)

Title

Neonatal Head Circumference in Part A and B

Description

Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.

Time Frame

At Birth and Follow-up (Week 12)

Title

Neonatal Length Measured at 4-6 Weeks of Age in Part A and B

Description

Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (approximately 4 to 6 weeks of age). Mean Neonatal length is presented.

Time Frame

At birth and follow-up (approximately 4 to 6 weeks of age)

Title

Description

Time Frame

Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion

Title

Derived Plasma GSK221149 Pharmacokinetic Parameters- Observed Elimination Half-life (T-half) and Time to Maximum Observed Drug Concentration (T-max)

Description

Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.

Time Frame

Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion

Title

Derived Plasma GSK221149 Pharmacokinetic Parameters- Maximum Plasma Concentration (Cmax)

Description

Blood samples (approximately 2 mL) were collected for the PK measurement of plasma GSK221149 at pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion.

Time Frame

Pre-dose, 2, 4, 8, 12, 24 and 48 (just before infusion was stopped) hours after the start of the infusion

Title

Neonatal Apgar Scores (at Birth) Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Description

Time Frame

1 minute and 5 minute after birth at 4 to 12 weeks post adjusted gestational age

Title

Neonatal Weight Gain Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Description

Neonatal safety was assessed through assessment of weight gain. Weight gain was measured at birth and follow-up (Week 12). Mean weight gain is presented.

Time Frame

At birth and Follow-up (Week 12)

Title

Neonatal Head Circumference Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Description

Neonatal safety was assessed through assessment of head circumference. Head circumference was measured at birth and follow-up (Week 12). Mean head circumference is presented.

Time Frame

At Birth and Follow-up (Week 12)

Title

Neonatal Length Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C

Description

Neonatal safety was assessed through assessment of neonatal length. Neonatal length was measured at birth and follow-up (Week 12). Mean neonatal length is presented.

Time Frame

At Birth and Follow-up (Week 12)

Title

Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C

Description

Time Frame

48 hours post-dose

Title

Percentage Reduction From Baseline in Number of Uterine Contractions [>30 Sec] Per Hour Within First 6 Hours of Therapy in Part C

Description

For uterine contraction assessment, an external tocodynamometer was fastened around the participant's abdomen. The number and duration of contraction was recorded at screening and up to 48 hours post-dose. Baseline was Day 0. Reduction from Baseline was calculated by subtracting Baseline values from post-Baseline values. Percentage reduction from Baseline in number of uterine contractions [>30 sec] per hour within first 6 hours of therapy are presented.

Time Frame

First 6 hours of therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85008

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85712

Country

United States

Facility Name

GSK Investigational Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

GSK Investigational Site

City

Colton

State/Province

California

ZIP/Postal Code

92324

Country

United States

Facility Name

GSK Investigational Site

City

Loma Linda

State/Province

California

ZIP/Postal Code

92350

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

GSK Investigational Site

City

Newark

State/Province

Delaware

ZIP/Postal Code

19718

Country

United States

Facility Name

GSK Investigational Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63023

Country

United States

Facility Name

GSK Investigational Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07101-1709

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

GSK Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Facility Name

GSK Investigational Site

City

Southern Pines

State/Province

North Carolina

ZIP/Postal Code

28388

Country

United States

Facility Name

GSK Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29201

Country

United States

Facility Name

GSK Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37403

Country

United States

Facility Name

GSK Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920-1511

Country

United States

Facility Name

GSK Investigational Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

GSK Investigational Site

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0587

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

GSK Investigational Site

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84124

Country

United States

Facility Name

GSK Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

GSK Investigational Site

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507-1914

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1181

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

1259

Country

Argentina

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Bogota

Country

Colombia

Facility Name

GSK Investigational Site

City

Bogotá

Country

Colombia

Facility Name

GSK Investigational Site

City

Clamart cedex

ZIP/Postal Code

92141

Country

France

Facility Name

GSK Investigational Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Paris cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

GSK Investigational Site

City

Poissy

ZIP/Postal Code

78300

Country

France

Facility Name

GSK Investigational Site

City

Suresnes

ZIP/Postal Code

92150

Country

France

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

GSK Investigational Site

City

Vilnius

ZIP/Postal Code

LT-10207

Country

Lithuania

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

00935

Country

Puerto Rico

Facility Name

GSK Investigational Site

City

Singapore

ZIP/Postal Code

229899

Country

Singapore

Facility Name

GSK Investigational Site

City

Barakaldo (Vizcaya)

ZIP/Postal Code

48903

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

GSK Investigational Site

City

Warwick

State/Province

Warwickshire

ZIP/Postal Code

CV34 5BW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

GSK Investigational Site

City

London

ZIP/Postal Code

W12 0NN

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

Citation

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.

Results Reference

background

PubMed Identifier

28556962

Citation

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.

Results Reference

background

PubMed Identifier

25819462

Citation

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. Erratum In: Br J Clin Pharmacol. 2015 Sep;80(3):609.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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

Obstetric Labour, Premature

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial