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

NCT ID: NCT02215954

Last Updated: 2017-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 637 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-12-31

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.

Conditions

Colon Cleansing in Preparation for Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment arm [1]: FE 999169

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

Group Type: EXPERIMENTAL

FE 999169

Intervention Type: DRUG

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.

Treatment arm [2]: FE 999169

Two sachets on the day before colonoscopy

Group Type: EXPERIMENTAL

FE 999169

Intervention Type: DRUG

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.

Treatment arm [3]: Niflec

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

Group Type: ACTIVE_COMPARATOR

Niflec

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Investigational site

Chiba, , Japan

Investigational site

Kanagawa, , Japan

Investigational site

Kochi, , Japan

Investigational site

Tokyo, , Japan

Countries

Japan

Other Identifiers

000176

Identifier Type: -

Identifier Source: org_study_id