Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep
Study Details
Study Description
Brief Summary
Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep:
2-sachets for oral solution in two divided doses given a night before (first dose - sachet) and approximately 5 hours prior to procedure (second dose - sachet) or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: PICOPREP "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. |
Drug: PicoPrep
PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids.
Other Names:
|
Active Comparator: HalfLytely HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Drug: HalfLytely
HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.
Drug: bisacodyl
Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist [Day 2]
Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization.
Secondary Outcome Measures
- Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist [Day 2]
Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary.
- Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? [Day 2]
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult
- Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? [Day 2]
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
- Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation [Day 2]
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad
- Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was [Day 2]
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad
- Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? [Day 2]
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
- Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? [Day 2]
Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no
- Participants With Treatment-Emergent Adverse Events (TEAEs) [up to one month]
Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, age 18 to 80 years, inclusive, being scheduled to undergo elective colonoscopy
-
Female patients should be post menopausal (women ≥ 45yrs with no menstrual period for at least 12 months without an alternative medical cause), be surgically sterile, or be using medically approved contraception, throughout the trial period
-
Females of childbearing potential must undergo a pregnancy test at screening and again at randomization
-
Subjects must have had more than or equal to 3 spontaneous bowel movements per week for one month prior to the colonoscopy
-
Subjects should be willing, able and competent to complete the entire procedure and to comply with study instructions
-
Written informed consent obtained prior to study
Exclusion Criteria:
-
Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
-
Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
-
Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures
-
Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo-obstruction, hypomotility syndrome)
-
Ascites
-
Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
-
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 (serum creatinine and potassium must be within normal limits)
-
Participation in an investigational study within 30 days prior to receiving study medication (or within 60 days for investigational drugs with an elimination half-life greater than 15 days)
-
Any clinically significant laboratory value at the screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
-
Hypersensitivity to active ingredients
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Clinical Research Associates | Huntsville | Alabama | United States | |
2 | Arkansas Gastroenterology | Sherwood | Arkansas | United States | |
3 | Connecticut Gastroenterology Institute | Bristol | Connecticut | United States | |
4 | Indiana University Hospital | Indianapolis | Indiana | United States | |
5 | Louisiana Research Center LLC | Shreveport | Louisiana | United States | |
6 | Piedmont Medical Research Associates | Winston-Salem | North Carolina | United States | |
7 | Hillmont GI, P.C. | Flourtown | Pennsylvania | United States | |
8 | ClinSearch | Chattanooga | Tennessee | United States | |
9 | Blue Ridge Medical Research | Lynchburg | Virginia | United States |
Sponsors and Collaborators
- Ferring Pharmaceuticals
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2009-01
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Period Title: Overall Study | ||
STARTED | 307 | 301 |
Safety Population (Treated) | 305 | 298 |
Intent to Treat Population | 304 | 297 |
COMPLETED | 304 | 295 |
NOT COMPLETED | 3 | 6 |
Baseline Characteristics
Arm/Group Title | PICOPREP | HalfLytely | Total |
---|---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. | Total of all reporting groups |
Overall Participants | 305 | 298 | 603 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
54.8
(10.04)
|
55.7
(10.00)
|
55.2
(10.02)
|
Sex: Female, Male (Count of Participants) | |||
Female |
181
59.3%
|
174
58.4%
|
355
58.9%
|
Male |
124
40.7%
|
124
41.6%
|
248
41.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
7
2.3%
|
5
1.7%
|
12
2%
|
Not Hispanic or Latino |
298
97.7%
|
293
98.3%
|
591
98%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Race/Ethnicity, Customized (participants) [Number] | |||
American Indian or Alaska Native |
1
0.3%
|
1
0.3%
|
2
0.3%
|
Asian |
0
0%
|
1
0.3%
|
1
0.2%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.3%
|
1
0.2%
|
Black or African American |
36
11.8%
|
27
9.1%
|
63
10.4%
|
White |
265
86.9%
|
268
89.9%
|
533
88.4%
|
Other |
3
1%
|
0
0%
|
3
0.5%
|
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [kg/m^2] |
29.4
(5.68)
|
29.6
(6.34)
|
29.5
(6.01)
|
Outcome Measures
Title | Percentage of Participants Classified as Successes (Excellent and Good Ratings) According to the Aronchick Scale As Assessed by a Blinded Gastroenterologist |
---|---|
Description | Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Aronchick scale. The Aronchick scale is a 4-step rating scale: inadequate, fair, good, and excellent. Excellent is defined as >90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization. Good is defined as >90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization. |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 304 | 297 |
Number [percentage of participants] |
84.2
27.6%
|
74.4
25%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | Non-inferiority was demonstrated if the 1-sided 97.5% CI for the treatment difference (PICOPREP minus HalfLytely) was >-9% for the percentage of responders. Superiority was demonstrated if the 1-sided 97.5% CI for treatment difference was >0%. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 9.8 | |
Confidence Interval |
(1-Sided) 97.5% 3.4 to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants Classified as Successes (Excellent, Good and Fair Ratings) According to the Ottawa Scale As Assessed by a Blinded Gastroenterologist |
---|---|
Description | Overall colon cleansing was assessed by a blinded gastroenterologist during the colonoscopy using the Ottawa scale, a 5-step rating scale: inadequate, poor, fair, good, and excellent. Excellent is defined as mucosal detail clearly visible; if fluid is present, it is clear and there is almost no stool residue. Good - some turbid fluid or stool residue but mucosal detail still visible; washing and suctioning is not necessary. Fair - turbid fluid or stool residue obscuring mucosal detail. However, mucosal detail becomes visible with suctioning and washing is not necessary. |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 304 | 297 |
Ascending colon |
89.5
29.3%
|
78.8
26.4%
|
Mid colon |
92.4
30.3%
|
85.9
28.8%
|
Recto-sigmoid colon |
92.4
30.3%
|
87.2
29.3%
|
Overall: ascending, mid, and recto-sigmoid colon |
86.8
28.5%
|
75.4
25.3%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | Ascending colon comparison | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 10.7 | |
Confidence Interval |
(1-Sided) 97.5% 4.9 to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | Mid colon comparison | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 6.6 | |
Confidence Interval |
(1-Sided) 97.5% 1.6 to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | Recto-sigmoid colon comparison | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 5.2 | |
Confidence Interval |
(1-Sided) 97.5% 0.4 to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | Overall: Ascending, mid, and recto-sigmoid colon comparison | |
Type of Statistical Test | Non-Inferiority or Equivalence | |
Comments | If the lower bound of the 97.5% confidence interval exceeds -9.0% then PicoPrep will be declared non-inferior to HalfLytely. If the non-inferiority test is satisfied then a test for superiority will be performed by comparing the lower bound of the 97.5% confidence interval with 0.0%. If the lower bound of the confidence interval is above 0.0% then superiority will be declared. | |
Statistical Test of Hypothesis | p-Value | |
Comments | ||
Method | ||
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 11.4 | |
Confidence Interval |
(1-Sided) 97.5% 5.2 to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: How Easy or Difficult Was It To Consume the Study Drug? |
---|---|
Description | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: very easy, easy, tolerable, difficult, very difficult |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 302 | 296 |
Very easy |
57.9
19%
|
8.1
2.7%
|
Easy |
31.5
10.3%
|
20.9
7%
|
Tolerable |
9.6
3.1%
|
47.0
15.8%
|
Difficult |
1.0
0.3%
|
14.9
5%
|
Very difficult |
0
0%
|
9.1
3.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Were You Able to Consume the Entire Prep As Instructed? |
---|---|
Description | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Two participants either did not complete the questionnaire or did not answer this question. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 303 | 296 |
Yes |
99.0
32.5%
|
89.9
30.2%
|
No |
1.0
0.3%
|
10.1
3.4%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Please Describe Your Overall Experience With the Study Preparation |
---|---|
Description | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Fair, Poor, Bad |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 301 | 296 |
Excellent |
46.8
15.3%
|
16.6
5.6%
|
Good |
45.2
14.8%
|
42.9
14.4%
|
Fair |
6.6
2.2%
|
28.7
9.6%
|
Poor |
1.0
0.3%
|
7.1
2.4%
|
Bad |
0.3
0.1%
|
4.7
1.6%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: The Taste of This Study Preparation Was |
---|---|
Description | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 5-point scale: Excellent, Good, Tolerable, Poor, Bad |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. One participant either did not complete the questionnaire or did not answer this question. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 303 | 297 |
Excellent |
23.4
7.7%
|
2.7
0.9%
|
Good |
50.5
16.6%
|
18.9
6.3%
|
Tolerable |
25.7
8.4%
|
56.2
18.9%
|
Poor |
0.3
0.1%
|
13.1
4.4%
|
Bad |
0
0%
|
9.1
3.1%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Wilcoxon (Mann-Whitney) | |
Comments |
Title | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Ask Your Doctor for This Preparation Again if You Need Another Colonoscopy in the Future? |
---|---|
Description | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Three participants either did not complete the questionnaire or did not answer this question. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 302 | 296 |
Yes |
96.0
31.5%
|
54.7
18.4%
|
No |
4.0
1.3%
|
45.3
15.2%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Percentage of Participants' Responses to the Acceptability and Tolerability Questionnaire: Would You Refuse the Same Preparation Again if it Were to be Prescribed to You in the Future? |
---|---|
Description | Participants answered the question above on Day 2 prior to the colonoscopy procedure. Answers were on a 2-point scale: yes, no |
Time Frame | Day 2 |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population of randomized and treated participants with efficacy assessments performed. Four participants either did not complete the questionnaire or did not answer this question. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 301 | 296 |
Yes |
1.7
0.6%
|
13.5
4.5%
|
No |
98.3
32.2%
|
86.5
29%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | PICOPREP, HalfLytely |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.0001 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Participants With Treatment-Emergent Adverse Events (TEAEs) |
---|---|
Description | Counts of participants who had TEAEs are summarized in a variety of categories. Severity and relatedness to study drug are in the opinion of the investigator. Severity is rated on a 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity), and severe (inability to work or perform usual activities). Only severe TEAEs are summarized. Relatedness is assessed on a 4-point scale: unrelated, unlikely, possibly and probably. Both possibly and probably answers are reported as 'related' to study medication. |
Time Frame | up to one month |
Outcome Measure Data
Analysis Population Description |
---|
Safety population of participants who were treated. |
Arm/Group Title | PICOPREP | HalfLytely |
---|---|---|
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. |
Measure Participants | 305 | 298 |
Any TEAE |
211
69.2%
|
217
72.8%
|
Death |
0
0%
|
0
0%
|
Serious AE |
1
0.3%
|
2
0.7%
|
TEAEs leading to discontinuation of study drug |
0
0%
|
1
0.3%
|
Severe TEAEs |
2
0.7%
|
6
2%
|
Related TEAEs |
19
6.2%
|
26
8.7%
|
Adverse Events
Time Frame | Treatment-emergent AEs occurring from Day 1 up to one month | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | PICOPREP | HalfLytely | ||
Arm/Group Description | "Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy. | HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets. | ||
All Cause Mortality |
||||
PICOPREP | HalfLytely | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
PICOPREP | HalfLytely | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/305 (0.3%) | 2/298 (0.7%) | ||
Gastrointestinal disorders | ||||
Pancreatitis acute | 1/305 (0.3%) | 0/298 (0%) | ||
General disorders | ||||
Non-cardiac chest pain | 0/305 (0%) | 1/298 (0.3%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Colon cancer | 0/305 (0%) | 1/298 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
PICOPREP | HalfLytely | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 166/305 (54.4%) | 177/298 (59.4%) | ||
Gastrointestinal disorders | ||||
Colonic polyp | 52/305 (17%) | 51/298 (17.1%) | ||
Diverticulum | 60/305 (19.7%) | 72/298 (24.2%) | ||
Diverticulum intestinal | 11/305 (3.6%) | 16/298 (5.4%) | ||
Haemorrhoids | 54/305 (17.7%) | 59/298 (19.8%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Colon adenoma | 56/305 (18.4%) | 51/298 (17.1%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Clinical Development Support |
---|---|
Organization | Ferring Pharmaceuticals |
Phone | |
DK0-Disclosure@ferring.com |
- 2009-01