Trial Outcomes & Findings for A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing (NCT NCT02215954)
NCT ID: NCT02215954
Last Updated: 2017-07-17
Results Overview
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.
COMPLETED
PHASE3
637 participants
Day 1 (day of colonoscopy)
2017-07-17
Participant Flow
Participant milestones
| Measure |
Treatment Arm [1]: FE 999169
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
Overall Study
STARTED
|
214
|
212
|
211
|
|
Overall Study
Intention-To-Treat (ITT) Analysis Set
|
214
|
212
|
211
|
|
Overall Study
Per Protocol (PP) Analysis Set
|
212
|
208
|
205
|
|
Overall Study
Safety Analysis Set
|
213
|
211
|
208
|
|
Overall Study
COMPLETED
|
213
|
211
|
205
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
6
|
Reasons for withdrawal
| Measure |
Treatment Arm [1]: FE 999169
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Not exposed
|
1
|
1
|
3
|
Baseline Characteristics
A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing
Baseline characteristics by cohort
| Measure |
Treatment Arm [1]: FE 999169
n=214 Participants
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=212 Participants
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=211 Participants
One to two pack(s) on the day of colonoscopy
Niflec
|
Total
n=637 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 14.3 • n=7 Participants
|
48.1 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
297 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
340 Participants
n=4 Participants
|
|
Height
|
1.64 (m)
STANDARD_DEVIATION 0.080 • n=5 Participants
|
1.64 (m)
STANDARD_DEVIATION 0.082 • n=7 Participants
|
1.64 (m)
STANDARD_DEVIATION 0.084 • n=5 Participants
|
1.64 (m)
STANDARD_DEVIATION 0.082 • n=4 Participants
|
|
Weight
|
61.9 (kg)
STANDARD_DEVIATION 11.6 • n=5 Participants
|
63.1 (kg)
STANDARD_DEVIATION 13.0 • n=7 Participants
|
62.6 (kg)
STANDARD_DEVIATION 12.5 • n=5 Participants
|
62.5 (kg)
STANDARD_DEVIATION 12.4 • n=4 Participants
|
|
Body Mass Index (BMI)
|
22.9 (kg/m2)
STANDARD_DEVIATION 3.20 • n=5 Participants
|
23.2 (kg/m2)
STANDARD_DEVIATION 3.59 • n=7 Participants
|
23.2 (kg/m2)
STANDARD_DEVIATION 3.72 • n=5 Participants
|
23.1 (kg/m2)
STANDARD_DEVIATION 3.51 • n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 (day of colonoscopy)Population: Intention-To-Treat Analysis set
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.
Outcome measures
| Measure |
Treatment Arm [1]: FE 999169
n=214 Participants
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=212 Participants
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=211 Participants
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
The Efficacy Rate Based on the Overall Colon Cleansing Effect as Assessed by the Independent Central Judging Committee Using the Japanese Colon Cleansing Scale
|
97.7 percentage of participants
|
92.0 percentage of participants
|
95.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (day of colonoscopy)Population: Intention-To-Treat Analysis set
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.
Outcome measures
| Measure |
Treatment Arm [1]: FE 999169
n=214 Participants
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=212 Participants
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=211 Participants
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
The Efficacy Rate Based on the Overall Colon Cleansing Effect Assessed by the Investigators at the Sites Using the Japanese Colon Cleansing Scale
|
88.8 percentage of participants
|
79.7 percentage of participants
|
93.4 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (day of colonoscopy)Population: Intention-To-Treat Analysis set
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).
Outcome measures
| Measure |
Treatment Arm [1]: FE 999169
n=214 Participants
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=212 Participants
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=211 Participants
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
The Total Scores of the Colon Cleansing Effect by the Investigators at Sites Using the Ottawa Scale
|
4.31 units on a scale
Interval 3.94 to 4.67
|
5.18 units on a scale
Interval 4.81 to 5.54
|
2.33 units on a scale
Interval 1.96 to 2.7
|
SECONDARY outcome
Timeframe: Day 0 - Day 1Population: Intention-To-Treat Analysis set
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)
Outcome measures
| Measure |
Treatment Arm [1]: FE 999169
n=214 Participants
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=212 Participants
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=211 Participants
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
IMP compliance, easy or difficult
|
1.86 units on a scale
Interval 1.75 to 1.97
|
1.98 units on a scale
Interval 1.87 to 2.08
|
3.08 units on a scale
Interval 2.97 to 3.19
|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
Overall impression of assigned IMP
|
2.07 units on a scale
Interval 1.97 to 2.18
|
2.10 units on a scale
Interval 2.0 to 2.21
|
2.85 units on a scale
Interval 2.75 to 2.95
|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
Taste of assigned IMP
|
2.08 units on a scale
Interval 1.96 to 2.19
|
2.23 units on a scale
Interval 2.12 to 2.35
|
3.19 units on a scale
Interval 3.08 to 3.31
|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
Volume of IMP consumption
|
2.90 units on a scale
Interval 2.84 to 2.97
|
2.89 units on a scale
Interval 2.82 to 2.96
|
2.23 units on a scale
Interval 2.17 to 2.3
|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
Comparison with previously colon cleansing
|
1.83 units on a scale
Interval 1.52 to 2.14
|
2.22 units on a scale
Interval 1.86 to 2.58
|
2.77 units on a scale
Interval 2.48 to 3.06
|
SECONDARY outcome
Timeframe: Day 0 - Day 1Population: Intention-To-Treat Analysis set
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
Outcome measures
| Measure |
Treatment Arm [1]: FE 999169
n=214 Participants
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=212 Participants
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=211 Participants
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
Wish to use the same drug in future
|
92.3 percentage of participants
Interval 87.8 to 95.2
|
88.5 percentage of participants
Interval 83.4 to 92.1
|
60.9 percentage of participants
Interval 54.0 to 67.3
|
|
Evaluation of Acceptability of the Investigational Medicinal Products (IMPs) by Subjects Using a Questionnaire
Refuse to use the same drug in future
|
2.7 percentage of participants
Interval 1.2 to 5.8
|
4.5 percentage of participants
Interval 2.4 to 8.3
|
11.2 percentage of participants
Interval 7.5 to 16.3
|
Adverse Events
Treatment Arm [1]: FE 999169
Treatment Arm [2]: FE 999169
Treatment Arm [3]: Niflec
Serious adverse events
| Measure |
Treatment Arm [1]: FE 999169
n=213 participants at risk
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=211 participants at risk
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=208 participants at risk
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
Gastrointestinal disorders
Post-procedual haemorrhage
|
0.00%
0/213
|
0.00%
0/211
|
0.48%
1/208 • Number of events 1
|
Other adverse events
| Measure |
Treatment Arm [1]: FE 999169
n=213 participants at risk
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy
FE 999169
|
Treatment Arm [2]: FE 999169
n=211 participants at risk
Two sachets on the day before colonoscopy
FE 999169
|
Treatment Arm [3]: Niflec
n=208 participants at risk
One to two pack(s) on the day of colonoscopy
Niflec
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.9%
4/213 • Number of events 5
|
1.4%
3/211 • Number of events 3
|
2.4%
5/208 • Number of events 5
|
|
Investigations
Blood magnesium increased
|
0.94%
2/213 • Number of events 2
|
2.8%
6/211 • Number of events 6
|
0.00%
0/208
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER