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.

October 20, 2020 updated by: Bayer

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38151
        • Merck Consumer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dosing arm 1
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
Drug: Mannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 2
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
Drug: Mannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 3
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
Drug: Mannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 4
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
Drug: Mannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
Experimental: Dosing arm 5
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Oral solution, 17g polyethylene glycol, one time
Drug: Mannitol
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 day
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
1 day
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
1 day
Number of Participants With/Without Cooling Sensation in the Products.
Time Frame: 1 day
Whether or not subjects felt a cooling sensation (yes/no).
1 day
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
1 day
Number of Participants With the Opinion of Aftertaste in the Products.
Time Frame: 1 day
Whether or not subjects experienced aftertaste (yes/no).
1 day
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
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With no Bowel Movement
Time Frame: 1 day
The number of subjects who did not report any bowel movement was evaluated.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
Number of Participants With Treatment Emergent Adverse Event
Time Frame: 1 day
Including serious adverse events and adverse events.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18160

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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