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.
- Conditions
- Constipation
- Interventions
- Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
- Registration Number
- NCT04534465
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dosing arm 3 Polyethylene glycol (MiraLAX, BAY81-8430) MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) Dosing arm 4 Polyethylene glycol (MiraLAX, BAY81-8430) MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) Dosing arm 1 Polyethylene glycol (MiraLAX, BAY81-8430) MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) Dosing arm 2 Polyethylene glycol (MiraLAX, BAY81-8430) MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) Dosing arm 5 Polyethylene glycol (MiraLAX, BAY81-8430) MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total) Dosing arm 1 Mannitol MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) Dosing arm 2 Mannitol MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) Dosing arm 3 Mannitol MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) Dosing arm 4 Mannitol MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) Dosing arm 5 Mannitol MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
- Primary Outcome Measures
Name Time Method 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
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 Aftertaste in the Products. 1 day Whether or not subjects experienced aftertaste (yes/no).
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
- Secondary Outcome Measures
Name Time Method 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.
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.
Number of Participants With Treatment Emergent Adverse Event 1 day Including serious adverse events and adverse events.
Number of Participants With no Bowel Movement 1 day The number of subjects who did not report any bowel movement was evaluated.
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 With no Successful Bowel Movement 1 day The number of subjects who did not report the successful bowel movement was evaluated.
Trial Locations
- Locations (1)
Merck Consumer Center
🇺🇸Memphis, Tennessee, United States