check_circleStudy Completed
Constipation
Bayer Identifier:
18127
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
CL2012-13-Evaluation of Oral Tolerance MiraLAX Solution
Trial purpose
The purpose of this study is to compare the safety and tolerability of oral ingestion of polyethylene glycol (PEG 3350) solution concentrate to oral ingestion of a placebo solution concentrate, in participants with constipation.
Key Participants Requirements
Sex
BothAge
18 - 75 YearsTrial summary
Enrollment Goal
65Trial Dates
June 2013 - October 2013Phase
Phase 2Could I Receive a placebo
YesProducts
Transipeg (Macrogol, BAY81-8430)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Madison, 53704, United States |
Primary Outcome
- Number of Participants With Inflammation of the Oral Mucosadate_rangeTime Frame:Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatmentenhanced_encryptionYesSafety Issue:
- Number of Participants With Inflammation of the Esophageal Mucosadate_rangeTime Frame:Visit 2 (Day 1) and Visit 3 (Day 17 ± 2 days), up to 19 days after start of treatmentenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Single BlindAssignment
Parallel AssignmentTrial Arms
2