Phase 2
N=29
The Safety, Tolerability And Metabolism Of GSK221149A, In Pregnant Women (30-36 Weeks), In Pre-Term Labor
Obstetric Labour, Premature
Bottom Line
View on ClinicalTrials.gov: NCT00404768 ↗Enrolled (actual)
29
Serious AEs
5.4%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Vital Sign Values of Potential Clinical Concern — 2; 4; 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GSK221149A (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Vital Sign Values of Potential Clinical Concern |
2; 4; 0; 3; 1; 4 | — |
| PRIMARY Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Concern |
13; 15; 8; 9 | — |
| PRIMARY Number of Participants With Clinical Chemistry and Hematology Parameter Values of Potential Clinical Concern |
10; 22; 7; 28 | — |
| PRIMARY Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) |
11; 14; 2; 17; 1; 2 | — |
| PRIMARY Assessment of Amniotic Fluid Index (AFI) |
17.21; 11.86; 16.88; 13.34; 18.34; 12.98 | — |
| PRIMARY Number of Participants With 50% Reduction in Uterine Contractions Per Hour in Part A and B |
9; 1 | — |
| PRIMARY Fetal Heart Rate Monitoring up to 48 Hours |
140.0; 137.3; 134.8; 139.8; 140.0; 138.4 | — |
| PRIMARY Number of Participants Achieving Uterine Quiescence |
9; 18; 2; 13 | — |
| SECONDARY Number of Participants With Preterm Births in Part C |
5; 16 | — |
| SECONDARY Neonatal Apgar Scores in Part A and B |
8.8; 9.0; 7.7; 8.2 | — |
| SECONDARY Neonatal Weight Gain in Part A and B |
3233.81; 3090.33; 4548.02; 4710.29 | — |
| SECONDARY Neonatal Head Circumference in Part A and B |
34.145; 35.903; 37.921; 36.667 | — |
| SECONDARY Neonatal Length Measured at 4-6 Weeks of Age in Part A and B |
50.3; 48.7; 54.6; 53.1 | — |
| SECONDARY 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]) |
429.73; 419.09 | — |
| SECONDARY Derived Plasma GSK221149 Pharmacokinetic Parameters- Observed Elimination Half-life (T-half) and Time to Maximum Observed Drug Concentration (T-max) |
1.534; 1.713 | — |
| SECONDARY Derived Plasma GSK221149 Pharmacokinetic Parameters- Maximum Plasma Concentration (Cmax) |
126.93 | — |
| SECONDARY Neonatal Apgar Scores (at Birth) Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C |
9.0; 8.9; 8.3; 8.2 | — |
| SECONDARY Neonatal Weight Gain Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C |
3098.63; 2940.03; 3427.14; 3601.79 | — |
| SECONDARY Neonatal Head Circumference Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C |
33.319; 33.080; 35.057; 35.160 | — |
| SECONDARY Neonatal Length Measured at 4 to 12 Weeks Post Adjusted Gestational Age in Part C |
47.8; 47.8; 50.6; 51.3 | — |
| SECONDARY Number of Participants Who Remained Undelivered Without Rescue Tocolytic Therapy After 48 Hours in Part C |
30; 34 | — |
| SECONDARY Percentage Reduction From Baseline in Number of Uterine Contractions [>30 Sec] Per Hour Within First 6 Hours of Therapy in Part C |
-26.29; -19.03; -36.65; -27.67; -49.14; -23.11 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00404768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.