Constipation
Conditions
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.
Interventions
DRUGPolyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
DRUGMannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Male and female subjects, aged 18 years and older, suffering with occasional constipation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Number of Participants With/Without Cooling Sensation in the Products. | 1 day | Whether or not subjects felt a cooling sensation (yes/no). |
| 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 |
| Number of Participants With the Opinion of Aftertaste in the Products. | 1 day | Whether or not subjects experienced aftertaste (yes/no). |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With no Bowel Movement | 1 day | The number of subjects who did not report any bowel movement was evaluated. |
| Number of Participants With Treatment Emergent Adverse Event | 1 day | Including serious adverse events and adverse events. |
| 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. |
| 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. |
| 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. |
| 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. |
| Number of Participants With no Successful Bowel Movement | 1 day | The number of subjects who did not report the successful bowel movement was evaluated. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Study was conducted in US from 13Feb2013 (first patient first visit) to 19Mar2013 (last patient last visit).
Pre-assignment details
Sixty-two (62) subjects was screened and fifty (50) subjected completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Population MiraLAX Sachet (17g) + Flavor blend (2g, 4g, 6g, 8g and 10g mannitol total). Baseline data were not collected separately for Arms/Groups. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | All Population |
|---|---|
| Age, Continuous | 43.9 Years |
| Race/Ethnicity, Customized African American | 25 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Caucasian | 24 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 6 / 10 | 3 / 10 | 4 / 10 | 7 / 10 | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
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
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With Different Levels of Aftertaste of the Products | 1 - Slightly Noticeable | 0 Participants |
| Dosing Arm 1 | Number of Participants With Different Levels of Aftertaste of the Products | 3 - Extremely Noticeable | 0 Participants |
| Dosing Arm 1 | Number of Participants With Different Levels of Aftertaste of the Products | 2 - Moderately Noticeable | 1 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Aftertaste of the Products | 2 - Moderately Noticeable | 1 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Aftertaste of the Products | 1 - Slightly Noticeable | 3 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Aftertaste of the Products | 3 - Extremely Noticeable | 0 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Aftertaste of the Products | 2 - Moderately Noticeable | 1 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Aftertaste of the Products | 1 - Slightly Noticeable | 4 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Aftertaste of the Products | 3 - Extremely Noticeable | 1 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Aftertaste of the Products | 1 - Slightly Noticeable | 3 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Aftertaste of the Products | 3 - Extremely Noticeable | 0 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Aftertaste of the Products | 2 - Moderately Noticeable | 5 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Aftertaste of the Products | 2 - Moderately Noticeable | 1 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Aftertaste of the Products | 1 - Slightly Noticeable | 4 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Aftertaste of the Products | 3 - Extremely Noticeable | 0 Participants |
Primary
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
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With Different Levels of Cooling Sensation of the Products | 1 - Barely Perceptible | 0 Participants |
| Dosing Arm 1 | Number of Participants With Different Levels of Cooling Sensation of the Products | 2 - Slightly Noticeable | 1 Participants |
| Dosing Arm 1 | Number of Participants With Different Levels of Cooling Sensation of the Products | 3 - Moderately Noticeable | 0 Participants |
| Dosing Arm 1 | Number of Participants With Different Levels of Cooling Sensation of the Products | 4 - Extremely Noticeable | 0 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Cooling Sensation of the Products | 1 - Barely Perceptible | 0 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Cooling Sensation of the Products | 4 - Extremely Noticeable | 0 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Cooling Sensation of the Products | 2 - Slightly Noticeable | 0 Participants |
| Dosing Arm 2 | Number of Participants With Different Levels of Cooling Sensation of the Products | 3 - Moderately Noticeable | 1 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Cooling Sensation of the Products | 4 - Extremely Noticeable | 0 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Cooling Sensation of the Products | 2 - Slightly Noticeable | 1 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Cooling Sensation of the Products | 3 - Moderately Noticeable | 2 Participants |
| Dosiing Arm 3 | Number of Participants With Different Levels of Cooling Sensation of the Products | 1 - Barely Perceptible | 0 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Cooling Sensation of the Products | 1 - Barely Perceptible | 0 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Cooling Sensation of the Products | 2 - Slightly Noticeable | 0 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Cooling Sensation of the Products | 4 - Extremely Noticeable | 0 Participants |
| Dosing Arm 4 | Number of Participants With Different Levels of Cooling Sensation of the Products | 3 - Moderately Noticeable | 2 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Cooling Sensation of the Products | 4 - Extremely Noticeable | 0 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Cooling Sensation of the Products | 3 - Moderately Noticeable | 0 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Cooling Sensation of the Products | 2 - Slightly Noticeable | 2 Participants |
| Dosing Arm 5 | Number of Participants With Different Levels of Cooling Sensation of the Products | 1 - Barely Perceptible | 1 Participants |
Primary
Number of Participants With the Opinion of Aftertaste in the Products.
Whether or not subjects experienced aftertaste (yes/no).
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With the Opinion of Aftertaste in the Products. | Yes | 1 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of Aftertaste in the Products. | No | 9 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of Aftertaste in the Products. | Yes | 4 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of Aftertaste in the Products. | No | 6 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of Aftertaste in the Products. | Yes | 6 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of Aftertaste in the Products. | No | 4 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of Aftertaste in the Products. | No | 2 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of Aftertaste in the Products. | Yes | 8 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of Aftertaste in the Products. | Yes | 5 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of Aftertaste in the Products. | No | 5 Participants |
Primary
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
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -3 - Extremely Weak | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 3 - Much Too Intense | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 2 - Moderately Intense | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -1 - Slightly Weak | 4 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -2 - Somewhat Weak | 1 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 0 - Just the Right Level of Flavor | 5 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 - Slightly Intense | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 - Slightly Intense | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 0 - Just the Right Level of Flavor | 8 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -2 - Somewhat Weak | 1 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -3 - Extremely Weak | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 2 - Moderately Intense | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -1 - Slightly Weak | 1 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 3 - Much Too Intense | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 0 - Just the Right Level of Flavor | 3 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -3 - Extremely Weak | 1 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -2 - Somewhat Weak | 2 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -1 - Slightly Weak | 3 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 - Slightly Intense | 1 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 2 - Moderately Intense | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 3 - Much Too Intense | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -1 - Slightly Weak | 2 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 - Slightly Intense | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -2 - Somewhat Weak | 1 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 3 - Much Too Intense | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 2 - Moderately Intense | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -3 - Extremely Weak | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 0 - Just the Right Level of Flavor | 7 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -1 - Slightly Weak | 1 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 3 - Much Too Intense | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 2 - Moderately Intense | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 1 - Slightly Intense | 1 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -2 - Somewhat Weak | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | -3 - Extremely Weak | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Amount of Flavor in the Products | 0 - Just the Right Level of Flavor | 8 Participants |
Primary
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
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 1- Extremely Dislike | 1 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 7- Extremely Like | 1 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 6- Moderately Like | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 3- Dislike Somewhat | 1 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 2- Moderately Dislike | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 4- Neither Like nor Dislike | 4 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Flavor | 5- Like Somewhat | 3 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 5- Like Somewhat | 1 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 4- Neither Like nor Dislike | 1 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 2- Moderately Dislike | 3 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 1- Extremely Dislike | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 6- Moderately Like | 3 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 3- Dislike Somewhat | 1 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Flavor | 7- Extremely Like | 1 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 4- Neither Like nor Dislike | 4 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 1- Extremely Dislike | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 2- Moderately Dislike | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 3- Dislike Somewhat | 1 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 5- Like Somewhat | 2 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 6- Moderately Like | 2 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Flavor | 7- Extremely Like | 1 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 3- Dislike Somewhat | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 5- Like Somewhat | 4 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 2- Moderately Dislike | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 7- Extremely Like | 2 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 6- Moderately Like | 4 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 1- Extremely Dislike | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Flavor | 4- Neither Like nor Dislike | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 3- Dislike Somewhat | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 7- Extremely Like | 4 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 6- Moderately Like | 2 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 5- Like Somewhat | 3 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 2- Moderately Dislike | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 1- Extremely Dislike | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Flavor | 4- Neither Like nor Dislike | 1 Participants |
Primary
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
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | -3 - No Sweetness Needed | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | 3 - Much Too Sweet | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | 2 - Moderately Sweet | 0 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | -1 - Needs to be a Little Sweeter | 7 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | -2 - Needs to be Moderately Sweeter | 1 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | 0 - Just the Right Level of Sweetness | 2 Participants |
| Dosing Arm 1 | Number of Participants With the Opinion of the Products' Sweetness | 1 - Slightly Too Sweet | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | 1 - Slightly Too Sweet | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | 0 - Just the Right Level of Sweetness | 3 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | -2 - Needs to be Moderately Sweeter | 1 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | -3 - No Sweetness Needed | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | 2 - Moderately Sweet | 0 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | -1 - Needs to be a Little Sweeter | 6 Participants |
| Dosing Arm 2 | Number of Participants With the Opinion of the Products' Sweetness | 3 - Much Too Sweet | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | 0 - Just the Right Level of Sweetness | 2 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | -3 - No Sweetness Needed | 1 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | -2 - Needs to be Moderately Sweeter | 1 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | -1 - Needs to be a Little Sweeter | 6 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | 1 - Slightly Too Sweet | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | 2 - Moderately Sweet | 0 Participants |
| Dosiing Arm 3 | Number of Participants With the Opinion of the Products' Sweetness | 3 - Much Too Sweet | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | -1 - Needs to be a Little Sweeter | 3 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | 1 - Slightly Too Sweet | 1 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | -2 - Needs to be Moderately Sweeter | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | 3 - Much Too Sweet | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | 2 - Moderately Sweet | 0 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | -3 - No Sweetness Needed | 1 Participants |
| Dosing Arm 4 | Number of Participants With the Opinion of the Products' Sweetness | 0 - Just the Right Level of Sweetness | 5 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | -1 - Needs to be a Little Sweeter | 2 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | 3 - Much Too Sweet | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | 2 - Moderately Sweet | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | 1 - Slightly Too Sweet | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | -2 - Needs to be Moderately Sweeter | 0 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | -3 - No Sweetness Needed | 1 Participants |
| Dosing Arm 5 | Number of Participants With the Opinion of the Products' Sweetness | 0 - Just the Right Level of Sweetness | 7 Participants |
Primary
Number of Participants With/Without Cooling Sensation in the Products.
Whether or not subjects felt a cooling sensation (yes/no).
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With/Without Cooling Sensation in the Products. | Yes | 1 Participants |
| Dosing Arm 1 | Number of Participants With/Without Cooling Sensation in the Products. | No | 9 Participants |
| Dosing Arm 2 | Number of Participants With/Without Cooling Sensation in the Products. | Yes | 1 Participants |
| Dosing Arm 2 | Number of Participants With/Without Cooling Sensation in the Products. | No | 9 Participants |
| Dosiing Arm 3 | Number of Participants With/Without Cooling Sensation in the Products. | Yes | 3 Participants |
| Dosiing Arm 3 | Number of Participants With/Without Cooling Sensation in the Products. | No | 7 Participants |
| Dosing Arm 4 | Number of Participants With/Without Cooling Sensation in the Products. | No | 8 Participants |
| Dosing Arm 4 | Number of Participants With/Without Cooling Sensation in the Products. | Yes | 2 Participants |
| Dosing Arm 5 | Number of Participants With/Without Cooling Sensation in the Products. | Yes | 3 Participants |
| Dosing Arm 5 | Number of Participants With/Without Cooling Sensation in the Products. | No | 7 Participants |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants for Abdominal Discomfort Rating | 0 | 3 Participants |
| Dosing Arm 1 | Number of Participants for Abdominal Discomfort Rating | 1 | 6 Participants |
| Dosing Arm 1 | Number of Participants for Abdominal Discomfort Rating | 2 | 0 Participants |
| Dosing Arm 1 | Number of Participants for Abdominal Discomfort Rating | 3 | 1 Participants |
| Dosing Arm 2 | Number of Participants for Abdominal Discomfort Rating | 0 | 5 Participants |
| Dosing Arm 2 | Number of Participants for Abdominal Discomfort Rating | 3 | 0 Participants |
| Dosing Arm 2 | Number of Participants for Abdominal Discomfort Rating | 1 | 3 Participants |
| Dosing Arm 2 | Number of Participants for Abdominal Discomfort Rating | 2 | 1 Participants |
| Dosiing Arm 3 | Number of Participants for Abdominal Discomfort Rating | 3 | 0 Participants |
| Dosiing Arm 3 | Number of Participants for Abdominal Discomfort Rating | 1 | 1 Participants |
| Dosiing Arm 3 | Number of Participants for Abdominal Discomfort Rating | 2 | 0 Participants |
| Dosiing Arm 3 | Number of Participants for Abdominal Discomfort Rating | 0 | 9 Participants |
| Dosing Arm 4 | Number of Participants for Abdominal Discomfort Rating | 0 | 4 Participants |
| Dosing Arm 4 | Number of Participants for Abdominal Discomfort Rating | 1 | 3 Participants |
| Dosing Arm 4 | Number of Participants for Abdominal Discomfort Rating | 3 | 0 Participants |
| Dosing Arm 4 | Number of Participants for Abdominal Discomfort Rating | 2 | 3 Participants |
| Dosing Arm 5 | Number of Participants for Abdominal Discomfort Rating | 3 | 0 Participants |
| Dosing Arm 5 | Number of Participants for Abdominal Discomfort Rating | 2 | 1 Participants |
| Dosing Arm 5 | Number of Participants for Abdominal Discomfort Rating | 1 | 3 Participants |
| Dosing Arm 5 | Number of Participants for Abdominal Discomfort Rating | 0 | 6 Participants |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants for Bloating Rating | 0 | 5 Participants |
| Dosing Arm 1 | Number of Participants for Bloating Rating | 1 | 2 Participants |
| Dosing Arm 1 | Number of Participants for Bloating Rating | 2 | 2 Participants |
| Dosing Arm 1 | Number of Participants for Bloating Rating | 3 | 1 Participants |
| Dosing Arm 2 | Number of Participants for Bloating Rating | 0 | 5 Participants |
| Dosing Arm 2 | Number of Participants for Bloating Rating | 3 | 0 Participants |
| Dosing Arm 2 | Number of Participants for Bloating Rating | 1 | 2 Participants |
| Dosing Arm 2 | Number of Participants for Bloating Rating | 2 | 3 Participants |
| Dosiing Arm 3 | Number of Participants for Bloating Rating | 3 | 1 Participants |
| Dosiing Arm 3 | Number of Participants for Bloating Rating | 1 | 5 Participants |
| Dosiing Arm 3 | Number of Participants for Bloating Rating | 2 | 3 Participants |
| Dosiing Arm 3 | Number of Participants for Bloating Rating | 0 | 1 Participants |
| Dosing Arm 4 | Number of Participants for Bloating Rating | 0 | 1 Participants |
| Dosing Arm 4 | Number of Participants for Bloating Rating | 1 | 4 Participants |
| Dosing Arm 4 | Number of Participants for Bloating Rating | 3 | 2 Participants |
| Dosing Arm 4 | Number of Participants for Bloating Rating | 2 | 3 Participants |
| Dosing Arm 5 | Number of Participants for Bloating Rating | 3 | 0 Participants |
| Dosing Arm 5 | Number of Participants for Bloating Rating | 2 | 3 Participants |
| Dosing Arm 5 | Number of Participants for Bloating Rating | 1 | 3 Participants |
| Dosing Arm 5 | Number of Participants for Bloating Rating | 0 | 4 Participants |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants for Gas Rating | 0 | 0 Participants |
| Dosing Arm 1 | Number of Participants for Gas Rating | 1 | 4 Participants |
| Dosing Arm 1 | Number of Participants for Gas Rating | 2 | 5 Participants |
| Dosing Arm 1 | Number of Participants for Gas Rating | 3 | 1 Participants |
| Dosing Arm 2 | Number of Participants for Gas Rating | 0 | 2 Participants |
| Dosing Arm 2 | Number of Participants for Gas Rating | 3 | 2 Participants |
| Dosing Arm 2 | Number of Participants for Gas Rating | 1 | 5 Participants |
| Dosing Arm 2 | Number of Participants for Gas Rating | 2 | 1 Participants |
| Dosiing Arm 3 | Number of Participants for Gas Rating | 3 | 3 Participants |
| Dosiing Arm 3 | Number of Participants for Gas Rating | 1 | 4 Participants |
| Dosiing Arm 3 | Number of Participants for Gas Rating | 2 | 1 Participants |
| Dosiing Arm 3 | Number of Participants for Gas Rating | 0 | 2 Participants |
| Dosing Arm 4 | Number of Participants for Gas Rating | 0 | 0 Participants |
| Dosing Arm 4 | Number of Participants for Gas Rating | 1 | 3 Participants |
| Dosing Arm 4 | Number of Participants for Gas Rating | 3 | 2 Participants |
| Dosing Arm 4 | Number of Participants for Gas Rating | 2 | 5 Participants |
| Dosing Arm 5 | Number of Participants for Gas Rating | 3 | 4 Participants |
| Dosing Arm 5 | Number of Participants for Gas Rating | 2 | 3 Participants |
| Dosing Arm 5 | Number of Participants for Gas Rating | 1 | 2 Participants |
| Dosing Arm 5 | Number of Participants for Gas Rating | 0 | 1 Participants |
Secondary
Number of Participants With no Bowel Movement
The number of subjects who did not report any bowel movement was evaluated.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dosing Arm 1 | Number of Participants With no Bowel Movement | 1 Participants |
| Dosing Arm 2 | Number of Participants With no Bowel Movement | 2 Participants |
| Dosiing Arm 3 | Number of Participants With no Bowel Movement | 1 Participants |
| Dosing Arm 4 | Number of Participants With no Bowel Movement | 1 Participants |
| Dosing Arm 5 | Number of Participants With no Bowel Movement | 1 Participants |
Secondary
Number of Participants With no Successful Bowel Movement
The number of subjects who did not report the successful bowel movement was evaluated.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dosing Arm 1 | Number of Participants With no Successful Bowel Movement | 7 Participants |
| Dosing Arm 2 | Number of Participants With no Successful Bowel Movement | 6 Participants |
| Dosiing Arm 3 | Number of Participants With no Successful Bowel Movement | 3 Participants |
| Dosing Arm 4 | Number of Participants With no Successful Bowel Movement | 5 Participants |
| Dosing Arm 5 | Number of Participants With no Successful Bowel Movement | 6 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Event
Including serious adverse events and adverse events.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dosing Arm 1 | Number of Participants With Treatment Emergent Adverse Event | Serious Adverse Event | 0 participants |
| Dosing Arm 1 | Number of Participants With Treatment Emergent Adverse Event | Adverse Event | 6 participants |
| Dosing Arm 2 | Number of Participants With Treatment Emergent Adverse Event | Serious Adverse Event | 0 participants |
| Dosing Arm 2 | Number of Participants With Treatment Emergent Adverse Event | Adverse Event | 3 participants |
| Dosiing Arm 3 | Number of Participants With Treatment Emergent Adverse Event | Serious Adverse Event | 0 participants |
| Dosiing Arm 3 | Number of Participants With Treatment Emergent Adverse Event | Adverse Event | 4 participants |
| Dosing Arm 4 | Number of Participants With Treatment Emergent Adverse Event | Adverse Event | 7 participants |
| Dosing Arm 4 | Number of Participants With Treatment Emergent Adverse Event | Serious Adverse Event | 0 participants |
| Dosing Arm 5 | Number of Participants With Treatment Emergent Adverse Event | Serious Adverse Event | 0 participants |
| Dosing Arm 5 | Number of Participants With Treatment Emergent Adverse Event | Adverse Event | 6 participants |
Secondary
Time to First Bowel Movement (In Hours)
The mean and standard deviation of the time to first bowel movement in hours were evaluated.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dosing Arm 1 | Time to First Bowel Movement (In Hours) | 6.672 Hours | Standard Deviation 6.367 |
| Dosing Arm 2 | Time to First Bowel Movement (In Hours) | 5.444 Hours | Standard Deviation 4.095 |
| Dosiing Arm 3 | Time to First Bowel Movement (In Hours) | 5.117 Hours | Standard Deviation 6.987 |
| Dosing Arm 4 | Time to First Bowel Movement (In Hours) | 2.470 Hours | Standard Deviation 1.464 |
| Dosing Arm 5 | Time to First Bowel Movement (In Hours) | 4.543 Hours | Standard Deviation 2.718 |
Secondary
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dosing Arm 1 | Time to First Successful Bowel Movement (In Hours) | 4.311 Hours | Standard Deviation 0.826 |
| Dosing Arm 2 | Time to First Successful Bowel Movement (In Hours) | 9.967 Hours | Standard Deviation 8.87 |
| Dosiing Arm 3 | Time to First Successful Bowel Movement (In Hours) | 8.462 Hours | Standard Deviation 9.64 |
| Dosing Arm 4 | Time to First Successful Bowel Movement (In Hours) | 3.587 Hours | Standard Deviation 1.759 |
| Dosing Arm 5 | Time to First Successful Bowel Movement (In Hours) | 4.683 Hours | Standard Deviation 3.34 |