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Trial record 2 of 8 for:    colon cleansing AND Ferring

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02215954
First Posted: August 13, 2014
Last Update Posted: July 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  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 Drug: FE 999169 Drug: Niflec Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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) ]
    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.


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) ]
    The efficacy rate was based on the overall colon cleansing effect as assessed by the investigators at sites: 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.

  • The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale [ Time Frame: Day 1 (day of colonoscopy) ]
    The total Ottawa scale score was calculated by adding the ratings (0 to 4) for each of the three colon segments, Ascending colon (ascending, cecum), Mid colon (transverse, descending), and Recto-sigmoid colon, in addition to the overall fluid quantity rating (0 (small), 1 (medium), or 2 (large) ). This gave a sum of 0 (best) to 12 (worst) for overall assessment of colon cleansing, and an additional 0 to 2 for the global fluid quantity rating. The final range of the score was from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).

  • Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire [ Time Frame: Day 0 - Day 1 ]

    The mean score of subjects who gave favourable impression on their assigned IMPs with 3 or 5 points scales, and the frequency of the response for yes/no questions was summarized in each of question for each treatment arm.

    • Ease of consuming the assigned IMPs with a scale of 1(Very easy) to 5 (Very difficult)
    • Overall impression of the assigned IMPs with a scale of 1(Excellent) to 5 (Bad)
    • Taste of the assigned IMPs with a scale of 1 (Excellent) to 5 (Bad)
    • Volume of the assigned IMPs with a scale of 1(Very much) to 3 (No problem)
    • Impression of the assigned IMPs compared with other colon cleansing products with a scale of 1 (Much better) to 5 (Much worse)

  • Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire [ Time Frame: Day 0 - Day 1 ]

    The frequency of the response for yes/no questions was summarized in each of question for each treatment arm.

    • Whether or not a subject will request for the assigned IMPs again when the next colonoscopy is needed, with yes-or-no answer
    • Whether or not a subject will refuse the assigned IMPs when it is prescribed for the next colonoscopy, with yes-or-no answer


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
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
Drug: 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.
Experimental: Treatment arm [2]: FE 999169
Two sachets on the day before colonoscopy
Drug: 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.
Active Comparator: Treatment arm [3]: Niflec
One to two pack(s) on the day of colonoscopy
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02215954     History of Changes
Other Study ID Numbers: 000176
First Submitted: August 12, 2014
First Posted: August 13, 2014
Results First Submitted: October 24, 2016
Results First Posted: July 17, 2017
Last Update Posted: July 17, 2017
Last Verified: April 2017