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PEG 3350 laxative plus electrolytes/Macrogol

Phase 2

Constipation | Small molecule | Gastrointestinal |Bayer AG|Last Updated: Mar 15, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

PEG 3350 laxative plus electrolytes/Macrogol · 1 trial · 1 indication

Phase 2 1
NCT01212445Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)Constipation
COMPLETED154 Analytics
PHASE2COMPLETED
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
Constipation
NCT01212445154
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Study Endpoints

Primary Endpoints

Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration
From time of study drug treatment up to 24 hours

A successful BM was defined as a BM with no straining or hard/lumpy stools.

Secondary Endpoints

Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration
From time of study drug administration up to 3 Days
Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration
From time of study drug treatment up to 12 hours
Mean Visual Analog Scale (VAS) Rating for BM Control
From time of study drug treatment up to 24 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PEG + E, 13.125 gEXPERIMENTALSingle sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time
PEG + E, 26.25 gEXPERIMENTALTwo sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time
PEG + E, 39.375 gEXPERIMENTALThree sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time

Interventions

NameTypeDescription
PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)DRUG13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
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Eligibility Criteria

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

Inclusion Criteria: * A willingness to participate in the study and comply with its procedures * Must be ambulatory * Male or female subjects aged 18 years or older who met two or more of the following modified Rome III-based criteria for constipation: (a) straining during at least 25% of defecatio...

Countries:Ireland
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