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Preference Evaluation of BLI800 for Colonoscopy
NCT04214301Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2019
- Primary completion
- Nov 2019
- Countries
- 1
- Sponsor
- Braintree Laboratories
- Modality
- Small Molecules, Drug Delivery Systems
- Conditions
- Gastrointestinal cleansing
01
Overview
Phase 4, open-label, single-arm trial of sodium sulfate + potassium sulfate + magnesium sulfate in Gastrointestinal cleansing, sponsored by Braintree Laboratories. Primary endpoint: Ease of Preparation Consumption at 2 days. Started Sep 2019; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
BLI800
BLI800 Bowel Preparation
03
Who it enrols
Adult outpatients (18-85) undergoing colonoscopy for a routinely accepted indication. Excludes patients with severe GI conditions (ileus, obstruction, severe UC/IBD), previous significant GI surgeries, severe renal/hepatic/cardiac insufficiency, insulin therapy, or impaired consciousness.
04
Endpoints
Primary
Ease of Preparation Consumption
Secondary
Preparation Compliance
Rating of Overall Experience
Comparison to Prior Preparation
Willingness to Repeat Preparation
Refuse if Prescribed Again
Rating of Aftertaste
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