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.

Constipation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04534465
• Other study ID #: 18160
• Status: Completed
• Phase: Phase 4
• Start date: February 13, 2013
• Est. completion date: March 19, 2013

Study information

• Verified date: October 2020
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 19, 2013
• Est. primary completion date: March 19, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years
• Eligibility: Male and female subjects, aged 18 years and older, suffering with occasional constipation

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Polyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
• Mannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

Locations

Country	Name	City	State
United States	Merck Consumer Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	1 day
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	1 day
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	1 day
Primary	Number of Participants With/Without Cooling Sensation in the Products.	Whether or not subjects felt a cooling sensation (yes/no).	1 day
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	1 day
Primary	Number of Participants With the Opinion of Aftertaste in the Products.	Whether or not subjects experienced aftertaste (yes/no).	1 day
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	1 day
Secondary	Number of Participants With no Bowel Movement	The number of subjects who did not report any bowel movement was evaluated.	1 day
Secondary	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
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.	1 day
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.	1 day
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.	1 day
Secondary	Number of Participants With no Successful Bowel Movement	The number of subjects who did not report the successful bowel movement was evaluated.	1 day
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.	1 day
Secondary	Number of Participants With Treatment Emergent Adverse Event	Including serious adverse events and adverse events.	1 day