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.

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Bayer

Status and phase

Completed
Phase 4

Conditions

Constipation

Treatments

Drug: Mannitol
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04534465
18160

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 5 patient groups

Dosing arm 1
Experimental group
Description:
MiraLAX Sachet (17g) + Flavor blend (2g mannitol total)
Treatment:
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Drug: Mannitol
Dosing arm 2
Experimental group
Description:
MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total)
Treatment:
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Drug: Mannitol
Dosing arm 3
Experimental group
Description:
MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total)
Treatment:
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Drug: Mannitol
Dosing arm 4
Experimental group
Description:
MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total)
Treatment:
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Drug: Mannitol
Dosing arm 5
Experimental group
Description:
MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)
Treatment:
Drug: Polyethylene glycol (MiraLAX, BAY81-8430)
Drug: Mannitol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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