Study Completed

Constipation

Bayer Identifier:

18160

ClinicalTrials.gov Identifier:

NCT04534465

EudraCT Number:

Not Available

EU CT Number:

Not Available

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.

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - 60 Years

Trial summary

Enrollment Goal

Trial Dates

February 2013 - March 2013

Phase

Phase 4

Could I Receive a placebo

Products

Macrogol/MiraLAX (polyethylene glycol, BAY81-8430)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Merck Consumer Center	Memphis, 38151, United States

Primary Outcome

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
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
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
Number of participants with/without cooling sensation in the products.
Whether or not subjects felt a cooling sensation (yes/no).
Time Frame:
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
Time Frame:
1 day
Number of participants with the opinion of aftertaste in the products.
Whether or not subjects experienced aftertaste (yes/no).
Time Frame:
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
Time Frame:
1 day

Secondary Outcome

Number of participants with no bowel movement
The number of subjects who did not report any bowel movement was evaluated.
Time Frame:
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.
Time Frame:
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.
Time Frame:
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.
Time Frame:
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.
Time Frame:
1 day
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
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
Number of participants with treatment emergent adverse event
Including serious adverse events and adverse events.
Time Frame:
1 day

Trial design

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.

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Non-randomized

Blinding

N/A

Assignment

Parallel Assignment

Trial Arms