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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02215954

Enrollment

637

Registered

2014-08-13

Start date

2014-09-30

Completion date

2014-12-31

Last updated

2017-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cleansing in Preparation for Colonoscopy

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.

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.

Interventions

DRUGFE 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.

DRUGNiflec

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Measure	Time frame	Description
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 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	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	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)

Countries

Japan

Participant flow

Participants by arm

Arm	Count
Treatment Arm [1]: FE 999169 One sachet on the day before colonoscopy, and another sachet on the day of colonoscopy FE 999169	214
Treatment Arm [2]: FE 999169 Two sachets on the day before colonoscopy FE 999169	212
Treatment Arm [3]: Niflec One to two pack(s) on the day of colonoscopy Niflec	211
Total	637

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	0	0	1
Overall Study	Not exposed	1	1	3
Overall Study	Withdrawal by Subject	0	0	2

Baseline characteristics

Characteristic	Treatment Arm [1]: FE 999169	Treatment Arm [2]: FE 999169	Treatment Arm [3]: Niflec	Total
Age, Continuous	48.1 years STANDARD_DEVIATION 14	48.3 years STANDARD_DEVIATION 14.3	48.1 years STANDARD_DEVIATION 14.1	48.2 years STANDARD_DEVIATION 14.1
Body Mass Index (BMI)	22.9 (kg/m2) STANDARD_DEVIATION 3.2	23.2 (kg/m2) STANDARD_DEVIATION 3.59	23.2 (kg/m2) STANDARD_DEVIATION 3.72	23.1 (kg/m2) STANDARD_DEVIATION 3.51
Height	1.64 (m) STANDARD_DEVIATION 0.08	1.64 (m) STANDARD_DEVIATION 0.082	1.64 (m) STANDARD_DEVIATION 0.084	1.64 (m) STANDARD_DEVIATION 0.082
Sex: Female, Male Female	102 Participants	100 Participants	95 Participants	297 Participants
Sex: Female, Male Male	112 Participants	112 Participants	116 Participants	340 Participants
Weight	61.9 (kg) STANDARD_DEVIATION 11.6	63.1 (kg) STANDARD_DEVIATION 13	62.6 (kg) STANDARD_DEVIATION 12.5	62.5 (kg) STANDARD_DEVIATION 12.4

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	6 / 213	9 / 211	5 / 208
serious Total, serious adverse events	0 / 213	0 / 211	1 / 208

Outcome results

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.

Time frame: Day 1 (day of colonoscopy)