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Josamycin

Phase 3

Prematurity | Small molecule | Other |Bayer AG|Trials Updated: Dec 29, 2011

Josamycin development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Jul 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment3,200

FDA Designations

No designations recorded

Josamycin clinical trials

Josamycin · 1 trial · 1 indication

Phase 3 1
NCT00718705Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)Prematurity
COMPLETED3,200 Analytics
PHASE3COMPLETED
Reduction of Spontaneous Prematurity by Antibiotic Treatment (Josamycin)
Prematurity
NCT007187053,200
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Study Endpoints

Primary Endpoints

Premature birth
between 22 and 37 completed weeks of pregnancy.

Secondary Endpoints

Antenatal :occurence of a miscarriage late
between 16 and 22 weeks of amenorrhoea
Antenatal : premature delivery
at week of amenorrhea <= 34, 32, 28
Antenatal : hospitalisation for risk of premature delivery
antenatal period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALjosamycin
2PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
JosamycinDRUGjosamycin with posology of 2 grams per day by oral way during 10 days
PlaceboDRUGPlacebo with posology of 2 grams per day by oral way during 10 days
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient older ≥ 18 years * French speaking * Women who have an amniocentesis between 15 and 20 weeks of amenorrhoea for an antenatal diagnosis * Affiliated to social security or an equivalent system * Karyotype analysis and ultrasound morphological normal (apart from minor sig...

Countries:France
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Competitive Landscape -Retinopathy of Prematurity 3 trials (matched to "Prematurity")

Top 1 of 2 competitors

CompanyTickerTrialsLead PhaseDrugs
BayerBAYRY2 - Aflibercept
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