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Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01212445
First received: September 29, 2010
Last updated: February 28, 2014
Last verified: February 2014
Results First Received: November 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Constipation
Intervention: Drug: Polyethylene Glycol plus Electrolytes (PEG+E)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PEG + E 13.125 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
PEG + E 26.25 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
PEG + E 39.375 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.

Participant Flow:   Overall Study
    PEG + E 13.125 g     PEG + E 26.25 g     PEG + E 39.375 g  
STARTED     52     51     51  
COMPLETED     52     51     51  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
PEG + E 13.125 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
PEG + E 26.25 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
PEG + E 39.375 g Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
Total Total of all reporting groups

Baseline Measures
    PEG + E 13.125 g     PEG + E 26.25 g     PEG + E 39.375 g     Total  
Number of Participants  
[units: participants]
  52     51     51     154  
Age  
[units: years]
Mean ± Standard Deviation
  45.9  ± 16.31     50.4  ± 14.27     43.3  ± 13.8     46.5  ± 14.85  
Gender  
[units: participants]
       
Female     48     44     41     133  
Male     4     7     10     21  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Successful Bowel Movement (BM) Within 24 Hours of PEG + E Administration   [ Time Frame: From time of study drug treatment up to 24 hours ]

2.  Secondary:   Number of Participants With Time To First Successful BM In 0 Days Through 0.5 Days, >0.5 Days Through 1.0 Days, or >1.0 Days Through 1.5 Days After PEG+E Administration   [ Time Frame: From time of study drug administration up to 3 Days ]

3.  Secondary:   Percentage of Participants With Successful BM Within 12 Hours of PEG+E Administration   [ Time Frame: From time of study drug treatment up to 12 hours ]

4.  Secondary:   Mean Visual Analog Scale (VAS) Rating for BM Control   [ Time Frame: From time of study drug treatment up to 24 hours ]

5.  Secondary:   Mean VAS Rating for Gas   [ Time Frame: From time of study drug treatment up to 24 hours ]

6.  Secondary:   Mean VAS Rating for Bloating   [ Time Frame: From time of study drug treatment up to 24 hours ]

7.  Secondary:   Mean VAS Rating for Abdominal Discomfort/Cramping   [ Time Frame: From time of study drug treatment up to 24 hours ]

8.  Secondary:   Mean Participant Global Assessment of Treatment   [ Time Frame: From time of study drug administration up to 2 Days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01212445     History of Changes
Other Study ID Numbers: P07515, 2010-021367-32
Study First Received: September 29, 2010
Results First Received: November 20, 2012
Last Updated: February 28, 2014
Health Authority: Ireland: Irish Medicines Board