Clinical trial NCT02215954: A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cleansing in Preparation for Colonoscopy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 637
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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)
* Ascites.
* 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

Primary outcomes:
measure: The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale
timeFrame: Day 1 (day of colonoscopy)
Secondary outcomes:
measure: The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale
timeFrame: Day 1 (day of colonoscopy)
measure: The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale
timeFrame: Day 1 (day of colonoscopy)
measure: Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
timeFrame: Day 0 - Day 1
measure: Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
timeFrame: Day 0 - Day 1
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Investigational site
city: Kanagawa
country: Japan
facility: Investigational site
city: Kochi
country: Japan
facility: Investigational site
city: Tokyo
country: Japan
facility: Investigational site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: