MedPath

Retosiban

Generic Name
Retosiban
Drug Type
Small Molecule
Chemical Formula
C27H34N4O5
CAS Number
820957-38-8
Unique Ingredient Identifier
GIE06H28OX
Background

Retosiban has been used in trials studying the treatment of Premature Labor and Obstetric Labour, Premature.

Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women

Phase 1
Completed
Conditions
Obstetric Labour, Premature
Interventions
First Posted Date
2015-03-03
Last Posted Date
2017-05-09
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
32
Registration Number
NCT02377414
Locations
πŸ‡ΊπŸ‡Έ

GSK Investigational Site, Glendale, California, United States

A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor

Phase 3
Terminated
Conditions
Obstetric Labour, Premature
Interventions
Drug: Placebo IV infusion
First Posted Date
2015-03-03
Last Posted Date
2020-07-28
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
25
Registration Number
NCT02377466
Locations
πŸ‡¬πŸ‡§

GSK Investigational Site, London, United Kingdom

Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

Phase 3
Completed
Conditions
Obstetric Labour, Premature
Interventions
First Posted Date
2014-11-17
Last Posted Date
2020-07-09
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
98
Registration Number
NCT02292784
Locations
πŸ‡¬πŸ‡§

GSK Investigational Site, London, United Kingdom

A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour

Phase 3
Terminated
Conditions
Obstetric Labour, Premature
Interventions
First Posted Date
2014-11-17
Last Posted Date
2020-07-29
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
97
Registration Number
NCT02292771
Locations
πŸ‡¬πŸ‡§

GSK Investigational Site, Sheffield, United Kingdom

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)

Phase 1
Completed
Conditions
Obstetric Labour, Premature
Interventions
Drug: EFZ 600 mg
First Posted Date
2013-06-04
Last Posted Date
2017-05-11
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
18
Registration Number
NCT01867996
Locations
πŸ‡ΊπŸ‡Έ

GSK Investigational Site, Baltimore, Maryland, United States

This Study Will Investigate the Effect of Single Oral Doses of Retosiban on Cardiac Repolarization, With Moxifloxacin as a Positive Control in Healthy Volunteers.

Phase 1
Completed
Conditions
Obstetric Labour, Premature
Interventions
First Posted Date
2012-10-08
Last Posted Date
2017-06-12
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
52
Registration Number
NCT01702376
Locations
πŸ‡ΊπŸ‡Έ

GSK Investigational Site, Baltimore, Maryland, United States

Absorption, Distribution, Metabolism And Excretion Study For GSK221149A

Phase 1
Completed
Conditions
Obstetric Labour, Premature
Premature Labor
First Posted Date
2007-04-09
Last Posted Date
2012-03-19
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
6
Registration Number
NCT00457925
Locations
πŸ‡ΊπŸ‡Έ

GSK Investigational Site, Madison, Wisconsin, United States

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

Phase 2
Completed
Conditions
Obstetric Labour, Premature
Interventions
Drug: Placebo
First Posted Date
2006-11-29
Last Posted Date
2018-01-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
93
Registration Number
NCT00404768
Locations
πŸ‡¬πŸ‡§

GSK Investigational Site, London, United Kingdom

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