Trial Outcomes & Findings for Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements. (NCT NCT04534465)
NCT ID: NCT04534465
Last Updated: 2020-11-12
Results Overview
Evaluated by 7-point scales: 1-extremely dislike, 2-moderately dislike, 3-dislike somewhat, 4-neither like nor dislike, 5-like somewhat, 6-moderately like, 7-extremely like
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
1 day
Results posted on
2020-11-12
Participant Flow
Study was conducted in US from 13Feb2013 (first patient first visit) to 19Mar2013 (last patient last visit).
Sixty-two (62) subjects was screened and fifty (50) subjected completed the study.
Participant milestones
| Measure |
Dosing Arm 1
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosing Arm 3
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.
Baseline characteristics by cohort
| Measure |
All Population
n=50 Participants
MiraLAX Sachet (17g) + Flavor blend (2g, 4g, 6g, 8g and 10g mannitol total). Baseline data were not collected separately for Arms/Groups.
|
|---|---|
|
Age, Continuous
|
43.9 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayEvaluated by 7-point scales: 1-extremely dislike, 2-moderately dislike, 3-dislike somewhat, 4-neither like nor dislike, 5-like somewhat, 6-moderately like, 7-extremely like
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With the Opinion of the Products' Flavor
1- Extremely Dislike
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Products' Flavor
2- Moderately Dislike
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Products' Flavor
3- Dislike Somewhat
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Products' Flavor
4- Neither Like nor Dislike
|
4 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Opinion of the Products' Flavor
5- Like Somewhat
|
3 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With the Opinion of the Products' Flavor
6- Moderately Like
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With the Opinion of the Products' Flavor
7- Extremely Like
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 1 dayEvaluated by 7-point scales: -3 -extremely weak, -2 -somewhat weak, -1 -slightly weak, 0 -just the right level of flavor, 1 -slightly intense, 2 -moderately intense, 3 -much too intense
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
-3 - Extremely Weak
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
-2 - Somewhat Weak
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
-1 - Slightly Weak
|
4 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
0 - Just the Right Level of Flavor
|
5 Participants
|
8 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
1 - Slightly Intense
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
2 - Moderately Intense
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Amount of Flavor in the Products
3 - Much Too Intense
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 dayEvaluated by 7-point scales: -3 -no sweetness needed, -2 -needs to be moderately sweeter, -1 -needs to be a little sweeter, 0 -just the right level of sweetness, 1 -slightly too sweet, 2 -moderately sweet, 3 -much too sweet
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With the Opinion of the Products' Sweetness
-3 - No Sweetness Needed
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With the Opinion of the Products' Sweetness
-2 - Needs to be Moderately Sweeter
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Products' Sweetness
-1 - Needs to be a Little Sweeter
|
7 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With the Opinion of the Products' Sweetness
0 - Just the Right Level of Sweetness
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With the Opinion of the Products' Sweetness
1 - Slightly Too Sweet
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Products' Sweetness
2 - Moderately Sweet
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With the Opinion of the Products' Sweetness
3 - Much Too Sweet
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 dayWhether or not subjects felt a cooling sensation (yes/no).
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With/Without Cooling Sensation in the Products.
Yes
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With/Without Cooling Sensation in the Products.
No
|
9 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 dayEvaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable
Outcome measures
| Measure |
Dosing Arm 1
n=1 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=1 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=3 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=2 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=3 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With Different Levels of Cooling Sensation of the Products
1 - Barely Perceptible
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Different Levels of Cooling Sensation of the Products
2 - Slightly Noticeable
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Different Levels of Cooling Sensation of the Products
3 - Moderately Noticeable
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Different Levels of Cooling Sensation of the Products
4 - Extremely Noticeable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 1 dayWhether or not subjects experienced aftertaste (yes/no).
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With the Opinion of Aftertaste in the Products.
Yes
|
1 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
|
Number of Participants With the Opinion of Aftertaste in the Products.
No
|
9 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 1 dayEvaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable
Outcome measures
| Measure |
Dosing Arm 1
n=1 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=4 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=6 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=8 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=5 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With Different Levels of Aftertaste of the Products
2 - Moderately Noticeable
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Different Levels of Aftertaste of the Products
1 - Slightly Noticeable
|
0 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Different Levels of Aftertaste of the Products
3 - Extremely Noticeable
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe number of subjects who did not report any bowel movement was evaluated.
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With no Bowel Movement
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe mean and standard deviation of the time to first bowel movement in hours were evaluated.
Outcome measures
| Measure |
Dosing Arm 1
n=9 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=8 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=9 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=9 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=9 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Time to First Bowel Movement (In Hours)
|
6.672 Hours
Standard Deviation 6.367
|
5.444 Hours
Standard Deviation 4.095
|
5.117 Hours
Standard Deviation 6.987
|
2.470 Hours
Standard Deviation 1.464
|
4.543 Hours
Standard Deviation 2.718
|
SECONDARY outcome
Timeframe: 1 dayA gas rating score of 0 means that there was no gas experienced, while a score of 1 represents slight gas experienced, 2 represents moderate gas experienced and 3 represents severe gas experienced.
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants for Gas Rating
0
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants for Gas Rating
1
|
4 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants for Gas Rating
2
|
5 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants for Gas Rating
3
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 1 dayA score of zero represents no bloating, while a score of 1 represents slight bloating, 2 represents moderate bloating and 3 represents severe bloating.
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants for Bloating Rating
0
|
5 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants for Bloating Rating
1
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants for Bloating Rating
2
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants for Bloating Rating
3
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayA score of 0 represents no abdominal pain, 1 represents slight abdominal pain, 2 represents moderate abdominal pain and 3 represents severe abdominal pain.
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=9 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants for Abdominal Discomfort Rating
0
|
3 Participants
|
5 Participants
|
9 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants for Abdominal Discomfort Rating
1
|
6 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants for Abdominal Discomfort Rating
2
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants for Abdominal Discomfort Rating
3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe number of subjects who did not report the successful bowel movement was evaluated.
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With no Successful Bowel Movement
|
7 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe mean and standard deviation of the time to first successful bowel movement in hours were evaluated.
Outcome measures
| Measure |
Dosing Arm 1
n=3 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=4 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=7 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=5 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=4 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Time to First Successful Bowel Movement (In Hours)
|
4.311 Hours
Standard Deviation 0.826
|
9.967 Hours
Standard Deviation 8.870
|
8.462 Hours
Standard Deviation 9.640
|
3.587 Hours
Standard Deviation 1.759
|
4.683 Hours
Standard Deviation 3.340
|
SECONDARY outcome
Timeframe: 1 dayIncluding serious adverse events and adverse events.
Outcome measures
| Measure |
Dosing Arm 1
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosiing Arm 3
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 Participants
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event
Serious Adverse Event
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment Emergent Adverse Event
Adverse Event
|
6 participants
|
3 participants
|
4 participants
|
7 participants
|
6 participants
|
Adverse Events
Dosing Arm 1
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dosing Arm 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dosing Arm 3
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dosing Arm 4
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Dosing Arm 5
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dosing Arm 1
n=10 participants at risk
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
|
Dosing Arm 2
n=10 participants at risk
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
|
Dosing Arm 3
n=10 participants at risk
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
|
Dosing Arm 4
n=10 participants at risk
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
|
Dosing Arm 5
n=10 participants at risk
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Increased Gas
|
30.0%
3/10 • 1 day
|
20.0%
2/10 • 1 day
|
20.0%
2/10 • 1 day
|
60.0%
6/10 • 1 day
|
50.0%
5/10 • 1 day
|
|
Gastrointestinal disorders
Increased Bloating
|
10.0%
1/10 • 1 day
|
0.00%
0/10 • 1 day
|
40.0%
4/10 • 1 day
|
0.00%
0/10 • 1 day
|
10.0%
1/10 • 1 day
|
|
Gastrointestinal disorders
Increased Abdominal Discomfort
|
20.0%
2/10 • 1 day
|
10.0%
1/10 • 1 day
|
0.00%
0/10 • 1 day
|
0.00%
0/10 • 1 day
|
10.0%
1/10 • 1 day
|
|
Gastrointestinal disorders
Watery Stool
|
10.0%
1/10 • 1 day
|
0.00%
0/10 • 1 day
|
30.0%
3/10 • 1 day
|
20.0%
2/10 • 1 day
|
10.0%
1/10 • 1 day
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • 1 day
|
0.00%
0/10 • 1 day
|
0.00%
0/10 • 1 day
|
0.00%
0/10 • 1 day
|
0.00%
0/10 • 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60