Back to resultsStudy 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.
Primary Purpose
Constipation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Polyethylene glycol (MiraLAX, BAY81-8430)
Mannitol
Sponsored by
About this trial
This is an interventional treatment trial for Constipation
Eligibility Criteria
Male and female subjects, aged 18 years and older, suffering with occasional constipation
Sites / Locations
- Merck Consumer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dosing arm 1
Dosing arm 2
Dosing arm 3
Dosing arm 4
Dosing arm 5
Arm 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)
Outcomes
Primary Outcome Measures
Number of Participants With the Opinion of the Products' Flavor
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
Number of Participants With the Opinion of the Amount of Flavor in the Products
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
Number of Participants With the Opinion of the Products' Sweetness
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
Number of Participants With/Without Cooling Sensation in the Products.
Whether or not subjects felt a cooling sensation (yes/no).
Number of Participants With Different Levels of Cooling Sensation of the Products
Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable
Number of Participants With the Opinion of Aftertaste in the Products.
Whether or not subjects experienced aftertaste (yes/no).
Number of Participants With Different Levels of Aftertaste of the Products
Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable
Secondary Outcome Measures
Number of Participants With no Bowel Movement
The number of subjects who did not report any bowel movement was evaluated.
Time to First Bowel Movement (In Hours)
The mean and standard deviation of the time to first bowel movement in hours were evaluated.
Number of Participants for Gas Rating
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.
Number of Participants for Bloating Rating
A score of zero represents no bloating, while a score of 1 represents slight bloating, 2 represents moderate bloating and 3 represents severe bloating.
Number of Participants for Abdominal Discomfort Rating
A score of 0 represents no abdominal pain, 1 represents slight abdominal pain, 2 represents moderate abdominal pain and 3 represents severe abdominal pain.
Number of Participants With no Successful Bowel Movement
The number of subjects who did not report the successful bowel movement was evaluated.
Time to First Successful Bowel Movement (In Hours)
The mean and standard deviation of the time to first successful bowel movement in hours were evaluated.
Number of Participants With Treatment Emergent Adverse Event
Including serious adverse events and adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04534465
Brief Title
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.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
February 13, 2013 (Actual)
Primary Completion Date
March 19, 2013 (Actual)
Study Completion Date
March 19, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dosing arm 1
Arm Type
Experimental
Arm Description
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
Arm Title
Dosing arm 2
Arm Type
Experimental
Arm Description
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
Arm Title
Dosing arm 3
Arm Type
Experimental
Arm Description
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
Arm Title
Dosing arm 4
Arm Type
Experimental
Arm Description
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
Arm Title
Dosing arm 5
Arm Type
Experimental
Arm Description
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Intervention Type
Drug
Intervention Name(s)
Polyethylene glycol (MiraLAX, BAY81-8430)
Intervention Description
Oral solution, 17g polyethylene glycol, one time
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Primary Outcome Measure Information:
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
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
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
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
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
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
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
Secondary Outcome Measure Information:
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
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
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
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
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
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
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
Title
Number of Participants With Treatment Emergent Adverse Event
Description
Including serious adverse events and adverse events.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male and female subjects, aged 18 years and older, suffering with occasional constipation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Merck Consumer Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38151
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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.
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