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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.

NCT ID: NCT04534465

Last Updated: 2020-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-13

Study Completion Date

2013-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dosing arm 1

MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)

Group Type EXPERIMENTAL

Polyethylene glycol (MiraLAX, BAY81-8430)

Intervention Type DRUG

Oral solution, 17g polyethylene glycol, one time

Mannitol

Intervention Type DRUG

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

Dosing arm 2

MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)

Group Type EXPERIMENTAL

Polyethylene glycol (MiraLAX, BAY81-8430)

Intervention Type DRUG

Oral solution, 17g polyethylene glycol, one time

Mannitol

Intervention Type DRUG

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

Dosing arm 3

MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)

Group Type EXPERIMENTAL

Polyethylene glycol (MiraLAX, BAY81-8430)

Intervention Type DRUG

Oral solution, 17g polyethylene glycol, one time

Mannitol

Intervention Type DRUG

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

Dosing arm 4

MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)

Group Type EXPERIMENTAL

Polyethylene glycol (MiraLAX, BAY81-8430)

Intervention Type DRUG

Oral solution, 17g polyethylene glycol, one time

Mannitol

Intervention Type DRUG

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

Dosing arm 5

MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)

Group Type EXPERIMENTAL

Polyethylene glycol (MiraLAX, BAY81-8430)

Intervention Type DRUG

Oral solution, 17g polyethylene glycol, one time

Mannitol

Intervention Type DRUG

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

Interventions

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Polyethylene glycol (MiraLAX, BAY81-8430)

Oral solution, 17g polyethylene glycol, one time

Intervention Type DRUG

Mannitol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Merck Consumer Center

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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18160

Identifier Type: -

Identifier Source: org_study_id