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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
637
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.
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.
Investigational site
Chiba, Japan
Investigational site
Kanagawa, Japan
Investigational site
Kochi, Japan
Investigational site
Tokyo, Japan
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.
Time frame: Day 1 (day of colonoscopy)
The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale
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.
Time frame: Day 1 (day of colonoscopy)
The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale
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).
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Time frame: Day 1 (day of colonoscopy)
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
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)
Time frame: Day 0 - Day 1
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
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
Time frame: Day 0 - Day 1