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.

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)

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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