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Completed

NCT Number: NCT04534465

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 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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Merck Consumer Center

Memphis, Tennessee, 38151, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyethylene glycol (MiraLAX, BAY81-8430)

Drug

Oral solution, 17g polyethylene glycol, one time

Mannitol

Drug

Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

Primary outcomes

  1. Number of Participants With the Opinion of the Products' Flavor

    Time frame: 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

  2. Number of Participants With the Opinion of the Amount of Flavor in the Products

    Time frame: 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

  3. Number of Participants With the Opinion of the Products' Sweetness

    Time frame: 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

  4. Number of Participants With/Without Cooling Sensation in the Products.

    Time frame: 1 day

    Whether or not subjects felt a cooling sensation (yes/no).

  5. Number of Participants With Different Levels of Cooling Sensation of the Products

    Time frame: 1 day

    Evaluated by 4-point scales: 1 -barely perceptible, 2 -slightly noticeable, 3 -moderately noticeable, 4 -extremely noticeable

  6. Number of Participants With the Opinion of Aftertaste in the Products.

    Time frame: 1 day

    Whether or not subjects experienced aftertaste (yes/no).

  7. Number of Participants With Different Levels of Aftertaste of the Products

    Time frame: 1 day

    Evaluated by 3-point scales: 1 -slightly noticeable, 2 -moderately noticeable, 3 -extremely noticeable

Secondary outcomes

  1. Number of Participants With no Bowel Movement

    Time frame: 1 day

    The number of subjects who did not report any bowel movement was evaluated.

  2. Time to First Bowel Movement (In Hours)

    Time frame: 1 day

    The mean and standard deviation of the time to first bowel movement in hours were evaluated.

  3. Number of Participants for Gas Rating

    Time frame: 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.

  4. Number of Participants for Bloating Rating

    Time frame: 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.

  5. Number of Participants for Abdominal Discomfort Rating

    Time frame: 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.

  6. Number of Participants With no Successful Bowel Movement

    Time frame: 1 day

    The number of subjects who did not report the successful bowel movement was evaluated.

  7. Time to First Successful Bowel Movement (In Hours)

    Time frame: 1 day

    The mean and standard deviation of the time to first successful bowel movement in hours were evaluated.

  8. Number of Participants With Treatment Emergent Adverse Event

    Time frame: 1 day

    Including serious adverse events and adverse events.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 1, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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