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.
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.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2013
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2013
CompletedFirst Submitted
Initial submission to the registry
August 27, 2020
CompletedFirst Posted
Study publicly available on registry
September 1, 2020
CompletedResults Posted
Study results publicly available
November 12, 2020
CompletedNovember 12, 2020
October 1, 2020
1 month
August 27, 2020
August 31, 2020
October 20, 2020
Conditions
Outcome Measures
Primary Outcomes (7)
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
1 day
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
1 day
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
1 day
Number of Participants With/Without Cooling Sensation in the Products.
Whether or not subjects felt a cooling sensation (yes/no).
1 day
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
1 day
Number of Participants With the Opinion of Aftertaste in the Products.
Whether or not subjects experienced aftertaste (yes/no).
1 day
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
1 day
Secondary Outcomes (8)
Number of Participants With no Bowel Movement
1 day
Time to First Bowel Movement (In Hours)
1 day
Number of Participants for Gas Rating
1 day
Number of Participants for Bloating Rating
1 day
Number of Participants for Abdominal Discomfort Rating
1 day
- +3 more secondary outcomes
Study Arms (5)
Dosing arm 1
EXPERIMENTALMiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
Dosing arm 2
EXPERIMENTALMiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
Dosing arm 3
EXPERIMENTALMiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
Dosing arm 4
EXPERIMENTALMiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
Dosing arm 5
EXPERIMENTALMiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Interventions
Oral solution, 17g polyethylene glycol, one time
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Merck Consumer Center
Memphis, Tennessee, 38151, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- Bayer
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2020
First Posted
September 1, 2020
Study Start
February 13, 2013
Primary Completion
March 19, 2013
Study Completion
March 19, 2013
Last Updated
November 12, 2020
Results First Posted
November 12, 2020
Record last verified: 2020-10