Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
PEG Laxative vs Placebo for Constipation from Medications
NCT00153127Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2001
- Primary completion
- Sep 2004
- Countries
- 1
- Sponsor
- Braintree Laboratories
- Modality
- Injectable Hydrogels, Implantable Hydrogels, Biodegradable Polymers
- Conditions
- constipation
01
Overview
Phase 4, randomised, double-blind trial in constipation comparing PEG 3350 with Placebo (2 arms). Primary endpoint: Successful Outcome (No longer meeting ROME I criteria). Started Nov 2001; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
PEG 3350
Polyethylene Glycol 3350
Placebo
Placebo Comparator
03
Who it enrols
Adult outpatients aged 19+ with constipation (ROME II criteria) caused by constipating medications, excluding those with IBS or significant GI obstruction/disease.
04
Endpoints
Primary
Successful Outcome (No longer meeting ROME I criteria)
Secondary
Analysis of individual ROME I criteria
Safety (adverse event and laboratory testing)
Beyond the preview
Go deeper on NCT00153127.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT00153127.