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Trial record 42 of 98 for:    grams | maltodextrin

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
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Constipation
Interventions Drug: Polyethylene glycol 3350
Other: Placebo, maltodextrin 500 powder for solution
Enrollment 203
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Polyethylene Glycol 3350 Powder for Solution Placebo
Hide Arm/Group Description MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days. MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
Period Title: Overall Study
Started 102 101
Completed 98 94
Not Completed 4 7
Reason Not Completed
Not specified             4             6
Non-compliance             0             1
Arm/Group Title Polyethylene Glycol 3350 Powder for Solution Placebo Total
Hide Arm/Group Description MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days. MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days. Total of all reporting groups
Overall Number of Baseline Participants 102 101 203
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 101 participants 203 participants
45.8  (12.52) 45.0  (14.15) 45.4  (13.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 101 participants 203 participants
Female
77
  75.5%
68
  67.3%
145
  71.4%
Male
25
  24.5%
33
  32.7%
58
  28.6%
1.Primary Outcome
Title Number of Participants With a Complete Resolution at the Final Visit
Hide Description 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.
Time Frame 24 hours to 3 days after last dose of seven day treatment period.
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title Polyethylene Glycol 3350 Powder for Solution Placebo
Hide Arm/Group Description:
MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
Overall Number of Participants Analyzed 98 94
Measure Type: Number
Unit of Measure: Participants
36 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Polyethylene Glycol 3350 Powder for Solution, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0595
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments The Cochran-Mantel-Haenszel adjusted for study site (the smallest study sites were pooled according to a pre-specified rule).
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Polyethylene Glycol 3350 Powder for Solution Placebo
Hide Arm/Group Description MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days. MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
All-Cause Mortality
Polyethylene Glycol 3350 Powder for Solution Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Polyethylene Glycol 3350 Powder for Solution Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/102 (0.00%)      0/101 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Polyethylene Glycol 3350 Powder for Solution Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/102 (10.78%)      11/101 (10.89%)    
Nervous system disorders     
Headache   11/102 (10.78%)  14 11/101 (10.89%)  11
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayer.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00770432     History of Changes
Other Study ID Numbers: 18130
CL2007-12
P08216 ( Other Identifier: Merck )
First Submitted: October 9, 2008
First Posted: October 10, 2008
Results First Submitted: June 24, 2009
Results First Posted: August 12, 2009
Last Update Posted: October 2, 2018