Conditions: Constipation
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: MiraLAX Sachet (17g) + Flavor blend (2g mannitol total) arm 2: MiraLAX Sachet (17g) + Flavor blend + additional 2g mannitol (4g mannitol total) arm 3: MiraLAX Sachet (17g) + Flavor blend + additional 4g mannitol (6g mannitol total) arm 4: MiraLAX Sachet (17g) + Flavor blend + additional 6g mannitol (8g mannitol total) arm 5: MiraLAX Sachet (17g) + Flavor blend + additional 8g mannitol (10g mannitol total)

Interventions: intervention 1: Polyethylene glycol (MiraLAX, BAY81-8430) intervention 2: Mannitol
Intervention descriptions: intervention 1: Oral solution, 17g polyethylene glycol, one time intervention 2: Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time

Protocol document: