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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Constipation

Intervention / Treatment
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* Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
* Drug: Mannitol


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With no Bowel Movement | The number of subjects who did not report any bowel movement was evaluated. | 1 day | 
| Time to First Bowel Movement (In Hours) | The mean and standard deviation of the time to first bowel movement in hours were evaluated. | 1 day | 
| 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. | 1 day | 
| 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. | 1 day | 
| 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. | 1 day | 
| Number of Participants With no Successful Bowel Movement | The number of subjects who did not report the successful bowel movement was evaluated. | 1 day | 
| 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. | 1 day | 
| Number of Participants With Treatment Emergent Adverse Event | Including serious adverse events and adverse events. | 1 day |