Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)
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|ClinicalTrials.gov Identifier: NCT00770432|
Recruitment Status : Completed
First Posted : October 10, 2008
Results First Posted : August 12, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Constipation||Drug: Polyethylene glycol 3350 Other: Placebo, maltodextrin 500 powder for solution||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Double-Blind, Trial of Polyethylene Glycol 3350 Laxative for the Treatment of Occasional Constipation.|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||January 2008|
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
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.
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