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 : October 2, 2018
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.
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