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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.

NCT04534465 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-11-12

Study results available
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Summary

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-13
Primary Completion
2013-03-19
Completion
2013-03-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534465 on ClinicalTrials.gov