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An Explorative Trial to Evaluate the Pharmacodynamic Effect of SPD557 on Reflux Parameters in Refractory GERD Patients

This study has been terminated.
(This study was terminated early due to recruitment difficulties. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01370863
First received: May 31, 2011
Last updated: June 25, 2014
Last verified: April 2014
Results First Received: April 15, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux Disease
Interventions: Drug: SPD557
Drug: placebo

  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
No text entered.

Reporting Groups
  Description
SPD557 0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
Placebo Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment

Participant Flow:   Overall Study
    SPD557   Placebo
STARTED   34   33 
COMPLETED   32   30 
NOT COMPLETED   2   3 
Adverse Event                1                1 
Did not want second pH/MII monitoring                1                1 
Not meeting inclusion/exclusion criteria                0                1 



  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.
The Safety Population was used defined as all subjects randomized into the study with at least 1 administration of the investigational product. Two subjects never received investigational product (n = 65).

Reporting Groups
  Description
SPD557 0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
Placebo Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
Total Total of all reporting groups

Baseline Measures
   SPD557   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 34   31   65 
Age 
[Units: Years]
Mean (Standard Deviation)
 43.8  (16.04)   45.8  (14.50)   44.8  (15.24) 
Age, Customized 
[Units: Participants]
     
Between 18 and 70 years inclusive   34   31   65 
Gender 
[Units: Participants]
     
Female   19   17   36 
Male   15   14   29 
Region of Enrollment [1] 
[Units: Participants]
     
France   13   13   26 
Belgium   8   7   15 
Netherlands   2   3   5 
Germany   4   4   8 
United Kingdom   3   4   7 
Switzerland   4   2   6 
[1] All randomized subjects (n = 67).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Number of Liquid-containing Reflux Events (pH/MII Monitoring) at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

2.  Secondary:   Change From Baseline in the Number of Days With Heartburn and/or Regurgitation at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]

3.  Secondary:   Change From Baseline in the Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Questionnaire at 4 Weeks   [ Time Frame: Baseline and 4 weeks ]


  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
Results data should be interpreted with caution since the study’s early termination affects the statistical power to detect true differences between treatment groups.


  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: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01370863     History of Changes
Other Study ID Numbers: SPD557-202
2010-021397-12 ( EudraCT Number )
Study First Received: May 31, 2011
Results First Received: April 15, 2013
Last Updated: June 25, 2014