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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm [1]: FE 999169 | Experimental | One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy |
|
| Treatment arm [2]: FE 999169 | Experimental | Two sachets on the day before colonoscopy |
|
| Treatment arm [3]: Niflec | Active Comparator | One to two pack(s) on the day of colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site | Chiba | Japan | ||||
| Investigational site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Arm [1]: FE 999169 | One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy FE 999169 |
| FG001 | Treatment Arm [2]: FE 999169 | Two sachets on the day before colonoscopy FE 999169 |
| FG002 | Treatment Arm [3]: Niflec | One to two pack(s) on the day of colonoscopy Niflec |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Intention-To-Treat Analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm [1]: FE 999169 | One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy FE 999169 |
| BG001 | Treatment Arm [2]: FE 999169 | Two sachets on the day before colonoscopy FE 999169 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-To-Treat Analysis set | Posted | Number | percentage of participants | Day 1 (day of colonoscopy) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Arm [1]: FE 999169 | One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy FE 999169 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-procedual haemorrhage | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment | The Investigator reported the event to be related with the endoscopic mucosal resection procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
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|
| 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. |
|
| 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). | 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.
| 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.
| Day 0 - Day 1 |
| Kanagawa |
| Japan |
| Investigational site | Kochi | Japan |
| Investigational site | Tokyo | Japan |
| Not exposed |
|
| BG002 | Treatment Arm [3]: Niflec | One to two pack(s) on the day of colonoscopy Niflec |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | (m) |
|
| Weight | Mean | Standard Deviation | (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | (kg/m2) |
|
| Treatment Arm [1]: FE 999169 |
One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy FE 999169 |
| OG001 | Treatment Arm [2]: FE 999169 | Two sachets on the day before colonoscopy FE 999169 |
| OG002 | Treatment Arm [3]: Niflec | One to two pack(s) on the day of colonoscopy Niflec |
|
|
| Secondary | 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. | Intention-To-Treat Analysis set | Posted | Number | percentage of participants | Day 1 (day of colonoscopy) |
|
|
|
| Secondary | 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). | Intention-To-Treat Analysis set | Posted | Mean | 95% Confidence Interval | units on a scale | Day 1 (day of colonoscopy) |
|
|
|
| Secondary | 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.
| Intention-To-Treat Analysis set | Posted | Mean | 95% Confidence Interval | units on a scale | Day 0 - Day 1 |
|
|
|
| Secondary | 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.
| Intention-To-Treat Analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Day 0 - Day 1 |
|
|
|
| 0 |
| 213 |
| 6 |
| 213 |
| EG001 | Treatment Arm [2]: FE 999169 | Two sachets on the day before colonoscopy FE 999169 | 0 | 211 | 9 | 211 |
| EG002 | Treatment Arm [3]: Niflec | One to two pack(s) on the day of colonoscopy Niflec | 1 | 208 | 5 | 208 |
|
| Blood magnesium increased | Investigations | MedDRA (17.0) | Non-systematic Assessment |
|
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.
| Overall impression of assigned IMP |
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| Taste of assigned IMP |
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| Volume of IMP consumption |
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| Comparison with previously colon cleansing |
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| Refuse to use the same drug in future |
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