NCT02215954

A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing

A Phase III, Randomized, Assessor-Blinded, Parallel-Group, Multi-Centre, Clinical Study With FE 999169 for Oral Administration Versus Niflec® for Colon Cleansing: J-CLEAR

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.

Detailed description

This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in Japanese patients. Patients, who signed an informed consent and fulfilled all screening criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: "FE 999169 Split Dosing Schedule", "FE 999169 Day Before Dosing Schedule" and " Niflec On the Day Dosing Schedule" in subjects requiring colonoscopy.

Conditions

• Colon Cleansing in Preparation for Colonoscopy

Interventions

Type	Name	Description
DRUG	FE 999169	FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration.
DRUG	Niflec	Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-08-13
• Last updated: 2017-07-17
• Results posted: 2017-07-17

Locations

4 sites across 1 country: Japan