Who is sponsoring NCT02215954?

NCT02215954 is sponsored by Ferring Pharmaceuticals.

What drugs are being tested in NCT02215954?

Interventions in NCT02215954: FE 999169, Niflec.

What condition does NCT02215954 study?

NCT02215954 studies Colon Cleansing in Preparation for Colonoscopy.

Is NCT02215954 still recruiting?

NCT02215954 is currently completed. Last updated 18 April 2017.

Are results published for NCT02215954?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-04-18 · How we verify

NCT02215954

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 18 April 2017

What this trial tests

Phase 3 trial testing FE 999169 in Colon Cleansing in Preparation for Colonoscopy in 637 participants. Completed in 1 December 2014.

Timeline

1 September 2014

Primary endpoint
1 December 2014

1 December 2014

Quick facts

Lead sponsor	Ferring Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	637
Start date	1 September 2014
Primary completion	1 December 2014
Estimated completion	1 December 2014
Sites	4 locations across Japan

Drugs / interventions tested

FE 999169 — full drug profile →
Niflec — full drug profile →

Conditions studied

Colon Cleansing in Preparation for Colonoscopy — all drugs for Colon Cleansing in Preparation for Colonoscopy →

Sponsor

Ferring Pharmaceuticals — full company profile →

Who can join

Adults 20 to 80, any sex, with Colon Cleansing in Preparation for Colonoscopy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale
Time frame: Day 1 (day of colonoscopy)
The efficacy rate was based on the overall colon cleansing effect as assessed by the independent central judging committee: the rate of responders who were defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale, which has scale of 1 (Excellent observation) to 5 (Unable to judge). One of the 5 ratings to each of the colon segments (rectum, sigmoid colon

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Ferring Pharmaceuticals trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02215954 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
Last refreshed: 18 April 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02215954.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing