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.

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04534465
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 5
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 44.8

Study Details

Study Description

Brief Summary

Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel movements. The taste of the various preparations will be measured by use of a rating scale.

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Drug: Mannitol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Center, Open-label, Parallel Arm, Phase 4 Study to Evaluate the Acceptability of a Prototype Flavor System With Ascending Levels of 2,4,6 Grams or Higher of Mannitol for PEG 3350 Laxative in Subjects Suffering With Occasional Constipation.
• Actual Study Start Date: Feb 13, 2013
• Actual Primary Completion Date: Mar 19, 2013
• Actual Study Completion Date: Mar 19, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dosing arm 1 MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 2 MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 3 MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 4 MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 5 MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)	Drug: Polyethylene glycol (MiraLAX, BAY81-8430); Oral solution, 17g polyethylene glycol, one time; Drug: Mannitol; Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

Outcome Measures

Primary Outcome Measures

1. Number of Participants With the Opinion of the Products' Flavor [1 day]

   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

2. Number of Participants With the Opinion of the Amount of Flavor in the Products [1 day]

   Evaluated 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

3. Number of Participants With the Opinion of the Products' Sweetness [1 day]

   Evaluated 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

4. Number of Participants With/Without Cooling Sensation in the Products. [1 day]

   Whether or not subjects felt a cooling sensation (yes/no).

5. Number of Participants With Different Levels of Cooling Sensation of the Products [1 day]

   Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable

6. Number of Participants With the Opinion of Aftertaste in the Products. [1 day]

   Whether or not subjects experienced aftertaste (yes/no).

7. Number of Participants With Different Levels of Aftertaste of the Products [1 day]

   Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable

Secondary Outcome Measures

1. Number of Participants With no Bowel Movement [1 day]

   The number of subjects who did not report any bowel movement was evaluated.

2. Time to First Bowel Movement (In Hours) [1 day]

   The mean and standard deviation of the time to first bowel movement in hours were evaluated.

3. Number of Participants for Gas Rating [1 day]

   A 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.

4. Number of Participants for Bloating Rating [1 day]

   A score of zero represents no bloating, while a score of 1 represents slight bloating, 2 represents moderate bloating and 3 represents severe bloating.

5. Number of Participants for Abdominal Discomfort Rating [1 day]

   A score of 0 represents no abdominal pain, 1 represents slight abdominal pain, 2 represents moderate abdominal pain and 3 represents severe abdominal pain.

6. Number of Participants With no Successful Bowel Movement [1 day]

   The number of subjects who did not report the successful bowel movement was evaluated.

7. Time to First Successful Bowel Movement (In Hours) [1 day]

   The mean and standard deviation of the time to first successful bowel movement in hours were evaluated.

8. Number of Participants With Treatment Emergent Adverse Event [1 day]

   Including serious adverse events and adverse events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Male and female subjects, aged 18 years and older, suffering with occasional constipation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merck Consumer Center	Memphis	Tennessee	United States	38151

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT04534465
• Other Study ID Numbers: 18160
• First Posted: Sep 1, 2020
• Last Update Posted: Nov 12, 2020
• Last Verified: Oct 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Constipation; Mannitol; Polyethylene glycol 3350

Study Results

Participant Flow

Recruitment Details	Study was conducted in US from 13Feb2013 (first patient first visit) to 19Mar2013 (last patient last visit).
Pre-assignment Detail	Sixty-two (62) subjects was screened and fifty (50) subjected completed the study.

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Period Title: Overall Study
STARTED	10	10	10	10	10
COMPLETED	10	10	10	10	10
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Population
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g, 4g, 6g, 8g and 10g mannitol total). Baseline data were not collected separately for Arms/Groups.
Overall Participants	50
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	43.9
Sex: Female, Male (Count of Participants)
Female	40 80%
Male	10 20%
Race/Ethnicity, Customized (participants) [Number]
African American	25 50%
Asian	1 2%
Caucasian	24 48%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With the Opinion of the Products' Flavor
Description	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
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
1- Extremely Dislike	1 2%	0 NaN	0 NaN	0 NaN	0 NaN
2- Moderately Dislike	0 0%	3 NaN	0 NaN	0 NaN	0 NaN
3- Dislike Somewhat	1 2%	1 NaN	1 NaN	0 NaN	0 NaN
4- Neither Like nor Dislike	4 8%	1 NaN	4 NaN	0 NaN	1 NaN
5- Like Somewhat	3 6%	1 NaN	2 NaN	4 NaN	3 NaN
6- Moderately Like	0 0%	3 NaN	2 NaN	4 NaN	2 NaN
7- Extremely Like	1 2%	1 NaN	1 NaN	2 NaN	4 NaN

2. Primary Outcome

Title	Number of Participants With the Opinion of the Amount of Flavor in the Products
Description	Evaluated 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
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
-3 - Extremely Weak	0 0%	0 NaN	1 NaN	0 NaN	0 NaN
-2 - Somewhat Weak	1 2%	1 NaN	2 NaN	1 NaN	0 NaN
-1 - Slightly Weak	4 8%	1 NaN	3 NaN	2 NaN	1 NaN
0 - Just the Right Level of Flavor	5 10%	8 NaN	3 NaN	7 NaN	8 NaN
1 - Slightly Intense	0 0%	0 NaN	1 NaN	0 NaN	1 NaN
2 - Moderately Intense	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
3 - Much Too Intense	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

3. Primary Outcome

Title	Number of Participants With the Opinion of the Products' Sweetness
Description	Evaluated 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
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
-3 - No Sweetness Needed	0 0%	0 NaN	1 NaN	1 NaN	1 NaN
-2 - Needs to be Moderately Sweeter	1 2%	1 NaN	1 NaN	0 NaN	0 NaN
-1 - Needs to be a Little Sweeter	7 14%	6 NaN	6 NaN	3 NaN	2 NaN
0 - Just the Right Level of Sweetness	2 4%	3 NaN	2 NaN	5 NaN	7 NaN
1 - Slightly Too Sweet	0 0%	0 NaN	0 NaN	1 NaN	0 NaN
2 - Moderately Sweet	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
3 - Much Too Sweet	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

4. Primary Outcome

Title	Number of Participants With/Without Cooling Sensation in the Products.
Description	Whether or not subjects felt a cooling sensation (yes/no).
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
Yes	1 2%	1 NaN	3 NaN	2 NaN	3 NaN
No	9 18%	9 NaN	7 NaN	8 NaN	7 NaN

5. Secondary Outcome

Title	Number of Participants With no Bowel Movement
Description	The number of subjects who did not report any bowel movement was evaluated.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
Count of Participants [Participants]	1 2%	2 NaN	1 NaN	1 NaN	1 NaN

6. Secondary Outcome

Title	Time to First Bowel Movement (In Hours)
Description	The mean and standard deviation of the time to first bowel movement in hours were evaluated.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	9	8	9	9	9
Mean (Standard Deviation) [Hours]	6.672 (6.367)	5.444 (4.095)	5.117 (6.987)	2.470 (1.464)	4.543 (2.718)

7. Secondary Outcome

Title	Number of Participants for Gas Rating
Description	A 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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
0	0 0%	2 NaN	2 NaN	0 NaN	1 NaN
1	4 8%	5 NaN	4 NaN	3 NaN	2 NaN
2	5 10%	1 NaN	1 NaN	5 NaN	3 NaN
3	1 2%	2 NaN	3 NaN	2 NaN	4 NaN

8. Secondary Outcome

Title	Number of Participants for Bloating Rating
Description	A score of zero represents no bloating, while a score of 1 represents slight bloating, 2 represents moderate bloating and 3 represents severe bloating.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
0	5 10%	5 NaN	1 NaN	1 NaN	4 NaN
1	2 4%	2 NaN	5 NaN	4 NaN	3 NaN
2	2 4%	3 NaN	3 NaN	3 NaN	3 NaN
3	1 2%	0 NaN	1 NaN	2 NaN	0 NaN

9. Secondary Outcome

Title	Number of Participants for Abdominal Discomfort Rating
Description	A score of 0 represents no abdominal pain, 1 represents slight abdominal pain, 2 represents moderate abdominal pain and 3 represents severe abdominal pain.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	9	10	10	10
0	3 6%	5 NaN	9 NaN	4 NaN	6 NaN
1	6 12%	3 NaN	1 NaN	3 NaN	3 NaN
2	0 0%	1 NaN	0 NaN	3 NaN	1 NaN
3	1 2%	0 NaN	0 NaN	0 NaN	0 NaN

10. Secondary Outcome

Title	Number of Participants With no Successful Bowel Movement
Description	The number of subjects who did not report the successful bowel movement was evaluated.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
Count of Participants [Participants]	7 14%	6 NaN	3 NaN	5 NaN	6 NaN

11. Primary Outcome

Title	Number of Participants With Different Levels of Cooling Sensation of the Products
Description	Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	1	1	3	2	3
1 - Barely Perceptible	0 0%	0 NaN	0 NaN	0 NaN	1 NaN
2 - Slightly Noticeable	1 2%	0 NaN	1 NaN	0 NaN	2 NaN
3 - Moderately Noticeable	0 0%	1 NaN	2 NaN	2 NaN	0 NaN
4 - Extremely Noticeable	0 0%	0 NaN	0 NaN	0 NaN	0 NaN

12. Primary Outcome

Title	Number of Participants With the Opinion of Aftertaste in the Products.
Description	Whether or not subjects experienced aftertaste (yes/no).
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
Yes	1 2%	4 NaN	6 NaN	8 NaN	5 NaN
No	9 18%	6 NaN	4 NaN	2 NaN	5 NaN

13. Primary Outcome

Title	Number of Participants With Different Levels of Aftertaste of the Products
Description	Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	1	4	6	8	5
1 - Slightly Noticeable	0 0%	3 NaN	4 NaN	3 NaN	4 NaN
2 - Moderately Noticeable	1 2%	1 NaN	1 NaN	5 NaN	1 NaN
3 - Extremely Noticeable	0 0%	0 NaN	1 NaN	0 NaN	0 NaN

14. Secondary Outcome

Title	Time to First Successful Bowel Movement (In Hours)
Description	The mean and standard deviation of the time to first successful bowel movement in hours were evaluated.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	3	4	7	5	4
Mean (Standard Deviation) [Hours]	4.311 (0.826)	9.967 (8.870)	8.462 (9.640)	3.587 (1.759)	4.683 (3.340)

15. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Event
Description	Including serious adverse events and adverse events.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dosing Arm 1	Dosing Arm 2	Dosiing Arm 3	Dosing Arm 4	Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)	MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Measure Participants	10	10	10	10	10
Serious Adverse Event	0 0%	0 NaN	0 NaN	0 NaN	0 NaN
Adverse Event	6 12%	3 NaN	4 NaN	7 NaN	6 NaN

Adverse Events

Time Frame	1 day
Arm/Group Title	Dosing Arm 1		Dosing Arm 2		Dosing Arm 3		Dosing Arm 4		Dosing Arm 5
Arm/Group Description	MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)		MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)		MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)		MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)		MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
All Cause Mortality
	Dosing Arm 1		Dosing Arm 2		Dosing Arm 3		Dosing Arm 4		Dosing Arm 5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Dosing Arm 1		Dosing Arm 2		Dosing Arm 3		Dosing Arm 4		Dosing Arm 5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Dosing Arm 1		Dosing Arm 2		Dosing Arm 3		Dosing Arm 4		Dosing Arm 5
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/10 (60%)		3/10 (30%)		4/10 (40%)		7/10 (70%)		6/10 (60%)
Gastrointestinal disorders
Increased Gas	3/10 (30%)		2/10 (20%)		2/10 (20%)		6/10 (60%)		5/10 (50%)
Increased Bloating	1/10 (10%)		0/10 (0%)		4/10 (40%)		0/10 (0%)		1/10 (10%)
Increased Abdominal Discomfort	2/10 (20%)		1/10 (10%)		0/10 (0%)		0/10 (0%)		1/10 (10%)
Watery Stool	1/10 (10%)		0/10 (0%)		3/10 (30%)		2/10 (20%)		1/10 (10%)
Nausea	1/10 (10%)		0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

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 results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.