At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 50 enrolled
Drug / intervention
Polyethylene glycol (MiraLAX, BAY81-8430) +1 moredrug
Likely dose
Polyethylene glycol (MiraLAX, BAY81-8430) 17gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Open-label, Parallel Arm, Phase 4 Study to Evaluate the Acceptability of a Prototype Flavor System With Ascending Levels of 2,4,6 Grams or Higher of Mannitol for PEG 3350 Laxative in Subjects Suffering With Occasional Constipation.
In Brief
A Phase 4 clinical trial evaluating Polyethylene glycol (MiraLAX, BAY81-8430) and Mannitol for Constipation. Completed, enrolled 50 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesUnited States
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2013
Primary CompletionMar 2013
First PostedSep 2020
TodayJul 2026
First PostedSep 1, 2020
Enrollment StartFeb 13, 2013
Primary CompletionMar 19, 2013
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.8 years ago
Interventions
Polyethylene glycol (MiraLAX, BAY81-8430)drug
Oral solution, 17g polyethylene glycol, one time
Mannitoldrug
Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time