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An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease (SHIELD-4)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01536418
First received: February 16, 2012
Last updated: July 19, 2017
Last verified: April 2017
Results First Received: April 6, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Crohn's Disease
Intervention: Drug: GSK1605786A

  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
A total of 253 participants, having moderate-to-severe Active Crohn’s Disease were randomized to the study. The study was conducted from 11 November 2011 to 17 October 2013, at 113 centers in 26 countries with sites in North America, Europe, Israel, Japan, Republic of Korea, Hong Kong, Taiwan, Australia and New Zealand.

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
GSK1605786A, 500 Milligram (mg), Once Daily Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
GSK1605786A, 500 mg Twice Daily Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.

Participant Flow:   Overall Study
    GSK1605786A, 500 Milligram (mg), Once Daily   GSK1605786A, 500 mg Twice Daily
STARTED   127   126 
COMPLETED   58   60 
NOT COMPLETED   69   66 
Protocol Violation                2                3 
Physician Decision                1                3 
Study closed/terminated                41                37 
Lack of Efficacy                10                16 
Adverse Event                9                4 
Met Liver Chemistry Stopping criteria                1                0 
Withdrawal by Subject                5                3 



  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.
No text entered.

Reporting Groups
  Description
GSK1605786A 500 mg, Once Daily Eligible participants in this arm received GSK1605786A 500 mg, once daily (two 250 mg capsules in the morning) , orally within 30 minutes of meals, for a period of 12 weeks.
GSK1605786A 500 mg, Twice Daily Eligible participants in this arm received GSK1605786A 500 mg twice daily (one 250 mg capsule in the morning and one 250 mg capsule in the evening), orally within 30 minutes of meals for a period of 12 weeks.
Total Total of all reporting groups

Baseline Measures
   GSK1605786A 500 mg, Once Daily   GSK1605786A 500 mg, Twice Daily   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   126   253 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.6  (13.11)   38.5  (12.91)   39.1  (13.00) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      63  49.6%      64  50.8%      127  50.2% 
Male      64  50.4%      62  49.2%      126  49.8% 
Race/Ethnicity, Customized 
[Units: Participants]
     
White-Caucasian/European   105   109   214 
White-Arabic/North African   104   105   209 
Black   1   4   5 
Asian-East   13   13   26 
Asian-South East   2   0   2 
Asian-Japanese   2   1   3 
Native Hawaiian/Pacific Islander   1   0   1 
Multiple race   2   1   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Achieving Clinical Response at Week 12   [ Time Frame: At Week 12 ]

2.  Secondary:   Percentage of Participants Achieving Clinical Remission at Week 8, Week 12 and at Both Week 8 and Week 12   [ Time Frame: Week 8 and Week 12 ]

3.  Secondary:   Percentage of Participants With a Clinical Response at Week 8 and at Both Week 8 and Week 12   [ Time Frame: Both Week 8 and Week 12 ]

4.  Secondary:   Change From Baseline in C-reactive Protein Concentration at Weeks 4, 8, and 12   [ Time Frame: Baseline (Screening) and Weeks 4, 8, and Week 12 ]

5.  Secondary:   Change From Baseline in Faecal Calprotectin at Week 12   [ Time Frame: Baseline (Screening) and Week 12 ]

6.  Secondary:   Pharmacokinetics (PK) of GSK1605786A   [ Time Frame: Baseline (Screening) and Week 12 ]

7.  Secondary:   Pharmacogenetic Analyses   [ Time Frame: Post randomization any time during early two 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
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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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01536418     History of Changes
Other Study ID Numbers: 114643
Study First Received: February 16, 2012
Results First Received: April 6, 2017
Last Updated: July 19, 2017