Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
NCT ID: NCT02292784
Last Updated: 2020-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2015-06-01
2019-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo (200719 study)
All infants and children born to women who received the placebo (0.9 percent sodium chloride infusion matched for retosiban volume, intravenous \[IV\] loading dose over 5 minutes and continuous infusion rate including dose increase in participants with an inadequate response any time after first hour of treatment) in 200719 study. Current study will not require any medical interventions or study visits to an investigational site.
Placebo
This is a safety follow-up study of infants and children exposed to matching placebo for retosiban/ atosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product
Retosiban (200719 and 200721 study)
All infants and children born to women who received retosiban (6 milligram \[mg\] IV loading dose of retosiban over 5 minutes followed by a 6 mg per hour continuous infusion of retosiban over 48 hours. Participants with an inadequate response any time after first hour of treatment were administered another 6 mg retosiban loading dose followed by 12 mg per hour continuous infusion for remainder of 48-hour treatment period) in 200719 study or 200721 study. Current study will not require any medical interventions or study visits to an investigational site.
Retosiban
This is a safety follow-up study of infants and children exposed to retosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
Atosiban (200721 study)
All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 mg using atosiban 6.75 mg per 0.9 milliliter \[mL\] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study will not require any medical interventions or study visits to an investigational site.
Atosiban
This is a safety follow-up study of infants and children exposed to atosiban comparator during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
Interventions
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Retosiban
This is a safety follow-up study of infants and children exposed to retosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
Atosiban
This is a safety follow-up study of infants and children exposed to atosiban comparator during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
Placebo
This is a safety follow-up study of infants and children exposed to matching placebo for retosiban/ atosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product
Eligibility Criteria
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Inclusion Criteria
* Infant is alive at 28 days post EDD.
* Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
10 Weeks
20 Weeks
ALL
No
Sponsors
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PPD Development, LP
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Park Ridge, Illinois, United States
GSK Investigational Site
Galveston, Texas, United States
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Jena, , Germany
GSK Investigational Site
Hadera, , Israel
GSK Investigational Site
Haifa, , Israel
GSK Investigational Site
Holon, , Israel
GSK Investigational Site
Kfar Saba, , Israel
GSK Investigational Site
Petah Tikva, , Israel
GSK Investigational Site
Safed, , Israel
GSK Investigational Site
Tel Aviv, , Israel
GSK Investigational Site
Siena, Tuscany, Italy
GSK Investigational Site
Monza, , Italy
GSK Investigational Site
Miyagi, , Japan
GSK Investigational Site
Miyazaki, , Japan
GSK Investigational Site
Guadalajara, Jalisco, Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico
GSK Investigational Site
Ciudad Obregón, Sonora, Mexico
GSK Investigational Site
Seongnam, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Zaragoza, , Spain
GSK Investigational Site
Uppsala, , Sweden
GSK Investigational Site
Sunderland, Tyne & Wear, United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
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References
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Powell M, Saade GR, Thornton S, Pimenta JM, Haque N, Miller D, Beach KJ, Snidow J, Correa EO, Scott R. Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Trials: ARIOS Follow-up Study. Am J Perinatol. 2023 Jul;40(10):1135-1148. doi: 10.1055/s-0041-1733784. Epub 2021 Aug 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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200722
Identifier Type: -
Identifier Source: org_study_id
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