Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)
This study has been completed.
First Posted: October 10, 2008
Last Update Posted: March 11, 2015
Information provided by (Responsible Party):
Randomized, placebo-controlled, double blind study. 203 subjects entered the study to compare the effect on occasional constipation of polyethylene glycol 3350 to placebo. Subjects took one of study treatments up to 7 days.
|Constipation||Drug: Polyethylene glycol 3350 Other: Placebo, maltodextrin 500 powder for solution||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind, Trial of Polyethylene Glycol 3350 Laxative for the Treatment of Occasional Constipation.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Number of Participants With a Complete Resolution at the Final Visit [ Time Frame: 24 hours to 3 days after last dose of seven day treatment period. ]A resolution was recorded if the participant has no occurrence of two or more consecutive unsuccessful bowel movements for the rest of the study following the first successful bowel movement.
Secondary Outcome Measures:
- Diary Ratings in Visual Analog Scale Format (Bowel Movement Control, Gas, Bloating, Abdominal Discomfort/Cramping, Well-being) [ Time Frame: 24 hours to 3 days after last dose of seven day treatment period. ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
- Binary Outcomes (Bowel Movement Satisfaction, Bowel Moevement Sense of Completion). [ Time Frame: 24 hours to 3 days after last dose of seven day treatment period. ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
|Study Start Date:||November 2007|
|Study Completion Date:||January 2008|
|Primary Completion Date:||January 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Polyethylene glycol 3350 powder for solution
MiraLAX® (polyethylene glycol 3350 powder for solution)
Drug: Polyethylene glycol 3350
Polyethylene glycol 3350 powder for solution. Single dose (17 grams in 4 to 8 ounces of beverage) for 7 days.
Other Name: MiraLAX®
Placebo Comparator: Placebo
MALTRIN 500® M500 (maltodextrin 500)
Other: Placebo, maltodextrin 500 powder for solution
Maltodextrin 500 powder for solution, One single dose (one capful) in any 4 - 8 ounces beverage for 7 days.
Other Name: MALTRIN® 500 powder for solution
Contacts and Locations
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