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The purpose of this study is to demonstrate that Eziclen is non-inferior to Fortrans® (the reference colonic lavage in Russia) administered in adult subjects scheduled to undergo colonoscopy for a routinely accepted diagnostic indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eziclen | Experimental |
| |
| Fortrans® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eziclen | Drug | Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS). | The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (<= 65; > 65), gender and inflammatory bowel disease (IBD) status. | Colonoscopy was performed on Day 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean BBPS Score by Segment and Globally (ITT Population) | The mean global BBPS scores and scores by colon segment are presented for the ITT population. For each of the 3 colon segments (right, transverse and left colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts:
The global score is the total of the 3 segment scores ranging from 0 - 9 (worst to best). Reconciled scores were based on 3 blinded reviews. Results of analysis for the PP population for right + transverse colon segments presented separately. |
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Inclusion Criteria:
Provision of written informed consent signed prior to any study related procedures
Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication:
In good clinical condition (physical exam and medical history)
Subjects with an adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, bicarbonate within normal/near normal range)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Healthcare Institution Municipal Clinical Hospital No. 31 of Moscow | Moscow | 119415 | Russia | |||
305 patients were screened for inclusion, and 296 patients met all inclusion criteria and none of the exclusion criteria and were randomised to treatment. 294 patients received study treatment, and 2 patients were excluded from the safety and intention-to-treat (ITT) populations as they did not receive study treatment prior to colonoscopy.
Adult patients due to undergo colonoscopy for a routine diagnostic indication were enrolled into this noninferiority phase 3 study at 3 study centres in Russia. First patient started: 13 March 2015; last patient completed: 28 December 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Eziclen | Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen. |
| FG001 | Fortrans® | Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Eziclen | Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen. |
| 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 | Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS). | The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas not well seen due to staining, residual stool and/or opaque liquid, 2=-minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well, 3=entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (<= 65; > 65), gender and inflammatory bowel disease (IBD) status. | The per protocol (PP) population consisted of all randomised patients who received the preparation of study treatment (complete or partial), who underwent the colonoscopy procedure and for whom no major protocol violation occurred until colonoscopy. Patients were assessed according to the randomised treatment, regardless of treatment received. | Posted | Number | 95% Confidence Interval | Adjusted percentage of patients |
Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
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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 | Eziclen | Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Proctitis | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
The differences in the Safety and ITT populations were due to 3 drug administration deviations. 2 patients initially randomized in the Fortrans® group received Eziclen and 1 patient initially randomized in the Eziclen group received Fortrans® .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen Pharma | clinical.trials@ipsen.com |
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| Fortrans® | Drug | Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy. |
|
| Colonoscopy was performed on Day 2. |
| Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population) | The mean colon segment BBPS scores for the Right Colon and Transverse Colon segments for the PP population are presented. For each of the colon segments (right and transverse colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts as follows:
Reconciled scores were based on the 3 blinded reviews. | Colonoscopy was performed on Day 2. |
| The Percentage of Patients in Whom Lesions Were Detected. | The percentage of patients for whom polyps, adenomas and other lesions were detected during the colonoscopy are presented. | Colonoscopy was performed on Day 2. |
| The Percentage of Patients for Whom the Colonoscopy Was Completed | The percentage of patients for whom a total colonoscopy could be completed is presented. | Colonoscopy was performed on Day 2. |
| Mean Colonoscopy Duration | The mean colonoscopy duration per treatment group is presented. The duration of colonoscopy was defined as the time from colonoscopy insertion to the time to reach the caecum in minutes. | Colonoscopy was performed on Day 2. |
| Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation | Investigator satisfaction with the procedure was measured by the mean Likert scale score for global evaluation by the investigator. The Likert scale consists of 5 points, and ranges from 0 (poor cleansing) to 4 (excellent cleansing) as follows:
| Colonoscopy was performed on Day 2. |
| Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment | Patient compliance was evaluated based on the percentage of patients who consumed all the planned volume of the study treatment. A patient was considered compliant with the instructions of use provided in the prescription if he/she drank the whole preparation and any required further fluid intake. The percentage of compliant patients is presented. | Study treatment was administered as a split-dose on Days 1 and 2. |
| Federal State Budgetary Institution "State Scientifical Center of Coloproctology" |
| Moscow |
| 123423 |
| Russia |
| State Healthcare Institution of Yaroslavl Region "Regional Clinical Cancer Hospital" | Yaroslavl | 150054 | Russia |
| BG001 |
| Fortrans® |
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®. |
| BG002 | Total Title |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | Mean BBPS Score by Segment and Globally (ITT Population) | The mean global BBPS scores and scores by colon segment are presented for the ITT population. For each of the 3 colon segments (right, transverse and left colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts:
The global score is the total of the 3 segment scores ranging from 0 - 9 (worst to best). Reconciled scores were based on 3 blinded reviews. Results of analysis for the PP population for right + transverse colon segments presented separately. | The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included. | Posted | Mean | Standard Deviation | units on a scale | Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population) | The mean colon segment BBPS scores for the Right Colon and Transverse Colon segments for the PP population are presented. For each of the colon segments (right and transverse colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts as follows:
Reconciled scores were based on the 3 blinded reviews. | The PP population consisted of all randomised patients who received the preparation of study treatment (whether complete or partial), who underwent the colonoscopy procedure and for whom no protocol violation occurred until colonoscopy. Patients were assessed according to the randomised treatment, regardless of treatment received. | Posted | Mean | Standard Deviation | units on a scale | Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | The Percentage of Patients in Whom Lesions Were Detected. | The percentage of patients for whom polyps, adenomas and other lesions were detected during the colonoscopy are presented. | The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Percentages are calculated based on the overall ITT population. | Posted | Number | percentage of participants | Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | The Percentage of Patients for Whom the Colonoscopy Was Completed | The percentage of patients for whom a total colonoscopy could be completed is presented. | The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. | Posted | Number | percentage of participants | Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | Mean Colonoscopy Duration | The mean colonoscopy duration per treatment group is presented. The duration of colonoscopy was defined as the time from colonoscopy insertion to the time to reach the caecum in minutes. | The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included. | Posted | Mean | Standard Deviation | minutes | Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation | Investigator satisfaction with the procedure was measured by the mean Likert scale score for global evaluation by the investigator. The Likert scale consists of 5 points, and ranges from 0 (poor cleansing) to 4 (excellent cleansing) as follows:
| The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included. | Posted | Mean | Standard Deviation | units on a scale | Colonoscopy was performed on Day 2. |
|
|
|
|
| Secondary | Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment | Patient compliance was evaluated based on the percentage of patients who consumed all the planned volume of the study treatment. A patient was considered compliant with the instructions of use provided in the prescription if he/she drank the whole preparation and any required further fluid intake. The percentage of compliant patients is presented. | The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. | Posted | Number | percentage of participants | Study treatment was administered as a split-dose on Days 1 and 2. |
|
|
|
|
| 0 |
| 147 |
| 1 |
| 147 |
| 101 |
| 147 |
| EG001 | Fortrans® | Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®. | 0 | 147 | 0 | 147 | 81 | 147 |
| Abdominal distension | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 17.1 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA version 17.1 | Systematic Assessment |
|
No publication of the Study Results shall be made without Sponsor's prior written approval. If a multi-centre publication is not submitted to a journal within 24 months after study conclusion at all sites the PI may individually publish results from the Institution Site subject to Sponsor's prior approval. Sponsor to be provided with final version of any abstract/presentation/paper prior to disclosure to provide scientific comments within 2 weeks for abstract/presentation or 6 weeks for article.
| Left Colon BBPS Score |
|
| Global BBPS Score |
|
Treatment difference for Transverse Colon BBPS Score. |
| ANOVA |
A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used. |
| =0.0382 |
| Adjusted difference |
| 0.11 |
| 2-Sided |
| 95 |
| 0.01 |
| 0.22 |
| Superiority |
| Treatment difference for Left Colon BBPS Score. | ANOVA | A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used. | =0.2538 | Adjusted difference | 0.06 | 2-Sided | 95 | -0.04 | 0.16 | Superiority |
| Treatment difference for Global BBPS Score. | ANOVA | A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used. | =0.0256 | Adjusted difference | 0.33 | 2-Sided | 95 | 0.04 | 0.62 | Superiority |
Treatment difference for Transverse Colon BBPS Score (per protocol population). |
| ANOVA |
A 2-way ANOVA with covariates for centre, age group (≤65; >65), gender and IBD status was used. |
| =0.1320 |
| Treatment difference |
| 0.08 |
| 2-Sided |
| 95 |
| -0.02 |
| 0.18 |
| Superiority |
| Other lesions detected |
|
Treatment difference for detection of adenomas. |
| Regression, Logistic |
A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used. |
| =0.6325 |
| Adjusted difference |
| 1.87 |
| 2-Sided |
| 95 |
| -6.25 |
| 9.99 |
| Superiority |
| Treatment difference for detection of other lesions. | Regression, Logistic | A multivariate logistic regression model, adjusted on centre, age class (≤65; >65), gender and IBD status was used. | =0.7086 | Adjusted difference | -1.55 | 2-Sided | 95 | -9.64 | 6.54 | Superiority |