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Study Comparing PEG 3350 Laxative to Placebo in the Treatment of Occasional Constipation (Study CL2007-12)(P08216)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00770432
First received: October 9, 2008
Last updated: January 12, 2011
Last verified: January 2011
History of Changes
Results First Received: June 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Constipation
Interventions: Drug: Polyethylene glycol 3350
Other: Placebo, maltodextrin 500 powder for solution

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Polyethylene Glycol 3350 Powder for Solution MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
Placebo MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.

Participant Flow:   Overall Study
    Polyethylene Glycol 3350 Powder for Solution     Placebo  
STARTED     102     101  
COMPLETED     98     94  
NOT COMPLETED     4     7  
Not specified                 4                 6  
Non-compliance                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Polyethylene Glycol 3350 Powder for Solution MiraLAX® (polyethylene glycol 3350 powder for solution). Single dose (17 grams dissolved in 4 to 8 ounces of beverage) for 7 days.
Placebo MALTRIN 500® M500 (maltodextrin 500 powder for solution). Single dose (one capful) in 4 to 8 ounces of beverage for 7 days.
Total Total of all reporting groups

Baseline Measures
    Polyethylene Glycol 3350 Powder for Solution     Placebo     Total  
Number of Participants  
[units: participants]
 		  102     101     203  
Age  
[units: years]
Mean ± Standard Deviation 		  45.8  ± 12.52     45.0  ± 14.15     45.4  ± 13.33  
Gender  
[units: participants]
 		     
Female     77     68     145  
Male     25     33     58  



  Outcome Measures

1.  Primary:   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. ]
  Show Outcome Measure 1

2.  Secondary:   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. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   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. ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00770432     History of Changes
Other Study ID Numbers: CL2007-12, P08216
Study First Received: October 9, 2008
Results First Received: June 24, 2009
Last Updated: January 12, 2011
Health Authority: United States: Institutional Review Board