| 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 | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
| | Units | Counts |
|---|
| Participants | - OG00010
- OG00110
- OG00210
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| 1- Extremely Dislike | |
|
| |
| 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 | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | |
|
| 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 | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | |
|
| Primary | Number of Participants With/Without Cooling Sensation in the Products. | Whether or not subjects felt a cooling sensation (yes/no). | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| Secondary | Number of Participants With no Bowel Movement | The number of subjects who did not report any bowel movement was evaluated. | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| Secondary | Time to First Bowel Movement (In Hours) | The mean and standard deviation of the time to first bowel movement in hours were evaluated. | | Posted | | Mean | Standard Deviation | Hours | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| 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. | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| 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. | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| 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. | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| Secondary | Number of Participants With no Successful Bowel Movement | The number of subjects who did not report the successful bowel movement was evaluated. | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| 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 | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| Primary | Number of Participants With the Opinion of Aftertaste in the Products. | Whether or not subjects experienced aftertaste (yes/no). | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| 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 | | Posted | | Count of Participants | | Participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| 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. | | Posted | | Mean | Standard Deviation | Hours | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
|
| Secondary | Number of Participants With Treatment Emergent Adverse Event | Including serious adverse events and adverse events. | | Posted | | Number | | participants | | 1 day | | | | ID | Title | Description |
|---|
| OG000 | Dosing Arm 1 | MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) | | OG001 | Dosing Arm 2 | MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) | | OG002 | Dosiing Arm 3 | MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) | | OG003 | Dosing Arm 4 | MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) | | OG004 | Dosing Arm 5 | MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) |
| |