Trial record 2 of 6 for:    colon cleansing AND Ferring

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02215954
First received: August 12, 2014
Last updated: January 16, 2015
Last verified: January 2015
  Purpose
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.

Condition Intervention Phase
Colon Cleansing in Preparation for Colonoscopy or Colorectal Surgery
Drug: FE 999169
Drug: Niflec
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    Rate of responders is defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale


Secondary Outcome Measures:
  • The efficacy rate based on the overall colon cleansing effect assessed by the investigators at the sites using the Japanese colon cleansing scale [ Time Frame: Day 1 (day of colonoscopy) ] [ Designated as safety issue: No ]
    Rate of responders is defined as subjects with a 1 or 2 rating in each colon segment on the Japanese colon cleansing scale

  • The total scores of the colon cleansing effect by the investigators at sites using the Ottawa scale [ Time Frame: Day 1 (day of colonoscopy) ] [ Designated as safety issue: No ]
  • Evaluation of acceptability of the investigational medicinal products (IMPs) by subjects using a questionnaire [ Time Frame: Day 0 - Day 1 ] [ Designated as safety issue: No ]

Enrollment: 637
Study Start Date: September 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm [1]: FE 999169
Split Dosing Schedule: the treatment starts one day before colonoscopy and completes on the day of colonoscopy
Drug: FE 999169
Experimental: Treatment arm [2]: FE 999169
Day Before Dosing Schedule: full treatment of 2 sachets of FE 999169 is administered on the day before colonoscopy
Drug: FE 999169
Active Comparator: Treatment arm [3]: Niflec
On the Day Dosing Schedule: full treatment of 1 to 2 pack(s) of Niflec is administered on the day of colonoscopy
Drug: Niflec

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese patients, age 20 to 80 years inclusive, requiring colonoscopy
  • Female patients should be post-menopausal (women ≥45 years with no menstrual period for at least 12 months without an alternative medical cause), or be surgically sterile, or be using medically approved contraception, throughout the trial period.
  • Fertile female patients must have a confirmed negative pregnancy test at screening and randomization
  • Patients must have had more than or equal to 3 spontaneous bowel movements per week prior to the colonoscopy
  • Written informed consent obtained prior to any study-related procedure

Exclusion Criteria:

  • Acute surgical abdominal conditions, such as acute intestinal obstruction or intestinal perforation, diverticulitis, appendicitis. If intestinal obstruction and perforation are suspected, perform appropriate diagnostic studies to rule out these conditions
  • Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
  • Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior endoscopic procedures
  • Colon disease (history of colonic cancer, toxic megacolon, idiopathic pseudo-obstruction, hypomotility syndrome)
  • Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
  • Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
  • Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months, Congestive Heart Failure (CHF), or uncontrolled hypertension
  • Renal insufficiency (any of the serum creatinine, or serum potassium value exceeding the upper limits of the normal range at screening) or a history of this event
  • Participation in any other clinical trial during the past 3 months
  • Any clinically significant laboratory value at screening, including pre-existing electrolyte abnormality, based on clinical history that the investigators feel may affect the study evaluation
  • Hypersensitivity to active ingredients
  • Subject who cannot suspend the prohibited medications
  • Subjects not appropriate to participate in the study as deemed by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02215954

Locations
Japan
Investigational site
Chiba, Japan
Investigational site
Kanagawa, Japan
Investigational site
Kochi, Japan
Investigational site
Tokyo, Japan
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02215954     History of Changes
Other Study ID Numbers: 000176 
Study First Received: August 12, 2014
Last Updated: January 16, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on February 04, 2016