Trial Condition(s):
Constipation
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.
Bayer Identifier:
18160
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Inclusion Criteria
No Inclusion Criteria Available
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Merck Consumer Center Memphis, United States, 38151 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
5
Primary Outcome
- Number of participants with the opinion of the products' flavorEvaluated 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 likeTimeframe: 1 day
- Number of participants with the opinion of the amount of flavor in the productsEvaluated 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 intenseTimeframe: 1 day
- Number of participants with the opinion of the products' sweetnessEvaluated 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 sweetTimeframe: 1 day
- Number of participants with/without cooling sensation in the products.Whether or not subjects felt a cooling sensation (yes/no).Timeframe: 1 day
- Number of participants with different levels of cooling sensation of the productsEvaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeableTimeframe: 1 day
- Number of participants with the opinion of aftertaste in the products.Whether or not subjects experienced aftertaste (yes/no).Timeframe: 1 day
- Number of participants with different levels of aftertaste of the productsEvaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeableTimeframe: 1 day
Secondary Outcome
- Number of participants with no bowel movementThe number of subjects who did not report any bowel movement was evaluated.Timeframe: 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.Timeframe: 1 day
- Number of participants for gas ratingA 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.Timeframe: 1 day
- Number of participants for bloating ratingA score of zero represents no bloating, while a score of 1 represents slight bloating, 2 represents moderate bloating and 3 represents severe bloating.Timeframe: 1 day
- Number of participants for abdominal discomfort ratingA score of 0 represents no abdominal pain, 1 represents slight abdominal pain, 2 represents moderate abdominal pain and 3 represents severe abdominal pain.Timeframe: 1 day
- Number of participants with no successful bowel movementThe number of subjects who did not report the successful bowel movement was evaluated.Timeframe: 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.Timeframe: 1 day
- Number of participants with treatment emergent adverse eventIncluding serious adverse events and adverse events.Timeframe: 1 day
Additional Information
Not Available
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