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

NCT02215954 | Completed Phase 3 Results

• 1 other identifier: 000176
• Study Type: interventional
• Target: 637
• Locations: 1 country
• Sites: 4

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.

Conditions

Colon Cleansing in Preparation for Colonoscopy

Outcome Measures

Primary Outcomes (1)

• The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale

  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, descending colon, transverse colon, and ascending colon/cecum) was given according to the description and the representative pictures of each rating. A subject who had a 1 or 2 rating in each colon segment was counted as a responder in the overall colon cleansing effect. Otherwise they were counted as a non-responder.

  Day 1 (day of colonoscopy)

Secondary Outcomes (4)

• The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale

  Day 1 (day of colonoscopy)

• The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale

  Day 1 (day of colonoscopy)

• Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire

  Day 0 - Day 1

• Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire

  Day 0 - Day 1

Study Arms (3)

Treatment arm [1]: FE 999169

EXPERIMENTAL

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

Drug: FE 999169

Treatment arm [2]: FE 999169

EXPERIMENTAL

Two sachets on the day before colonoscopy

Drug: FE 999169

Treatment arm [3]: Niflec

ACTIVE COMPARATOR

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

Drug: Niflec

Interventions

FE 999169 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 [1]: FE 999169; Treatment arm [2]: FE 999169

Niflec 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.

Treatment arm [3]: Niflec

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (4)

Investigational site

Chiba, Japan

Location

Investigational site

Kanagawa, Japan

Location

Investigational site

Kochi, Japan

Location

Investigational site

Tokyo, Japan

Location

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 13, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 17, 2017
• Results First Posted: July 17, 2017

Record last verified: 2017-04

Locations

JP (4)