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

Ferring

Status and phase: Completed; Phase 3

Conditions: Colon Cleansing in Preparation for Colonoscopy

Treatments: Drug: Niflec; Drug: FE 999169

Study type: Interventional

Funder types: Industry

Identifiers

NCT02215954

000176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 637 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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637 participants in 3 patient groups

Treatment arm [1]: FE 999169

Experimental group

Description:

One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy

Treatment:

Drug: FE 999169

Treatment arm [2]: FE 999169

Experimental group

Description:

Two sachets on the day before colonoscopy

Treatment:

Drug: FE 999169

Treatment arm [3]: Niflec

Active Comparator group

Description:

One to two pack(s) on the day of colonoscopy

Treatment:

Drug: Niflec