Open-Label Extension Study of GSK1605786A
Public ClinicalTrials.gov record NCT01318993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Extension Study to Assess the Safety of GSK1605786A in Subjects With Crohn's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
An open-label study to evaluate the safety and effectiveness of GSK1605786A 500 mg twice daily over 108 weeks in adult subjects with Crohn's disease. Subjects completing previous GSK-sponsored studies with GSK1605786A or subjects who withdraw early from Study CCX114157 (maintenance study of GSK1605786A) due to worsening of Crohn's disease requiring a treatment change may be eligible to participate. The primary objective is to evaluate the safety of GSK1605786A, as assessed by recording of adverse events, clinical laboratory parameters, vital signs and electrocardiogram. Secondary objectives will include assessments of effectiveness of long-term treatment with GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work and Productivity Activity Impairment-Crohn's Disease (WPAI-CD) and receipt of disability.
Study identification
- NCT ID
- NCT01318993
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 399 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2011 (Type not available)
- Primary completion
- Sep 1, 2013 (Actual)
- Completion
- Oct 29, 2013 (Actual)
- Last update posted
- Sep 14, 2017
2011 – 2013
United States locations
- U.S. sites
- 55
- U.S. states
- 27
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Little Rock | Arizona | 72205 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Anaheim | California | 92801 | — |
| GSK Investigational Site | La Jolla | California | 92093 | — |
| GSK Investigational Site | San Diego | California | 92103 | — |
| GSK Investigational Site | San Francisco | California | 94115 | — |
| GSK Investigational Site | Aurora | Colorado | 80045 | — |
| GSK Investigational Site | Lakewood | Colorado | 80215 | — |
| GSK Investigational Site | Littleton | Colorado | 80120 | — |
| GSK Investigational Site | Hamden | Connecticut | 06518 | — |
| GSK Investigational Site | New Haven | Connecticut | 06510 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | — |
| GSK Investigational Site | Jacksonville | Florida | 32256-6004 | — |
| GSK Investigational Site | Port Orange | Florida | 32127 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342-5006 | — |
| GSK Investigational Site | Suwanee | Georgia | 30024 | — |
| GSK Investigational Site | Chicago | Illinois | 60637 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46237 | — |
| GSK Investigational Site | Lexington | Kentucky | 40536-0298 | — |
| GSK Investigational Site | Hammond | Louisiana | 70403 | — |
| GSK Investigational Site | Monroe | Louisiana | 71201 | — |
| GSK Investigational Site | Chevy Chase | Maryland | 20815 | — |
| GSK Investigational Site | Towson | Maryland | 21204 | — |
| GSK Investigational Site | Towson | Maryland | 21286 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Ann Arbor | Michigan | 48109-5682 | — |
| GSK Investigational Site | Chesterfield | Michigan | 48047 | — |
| GSK Investigational Site | Troy | Michigan | 48098 | — |
| GSK Investigational Site | Rochester | Minnesota | 55905 | — |
| GSK Investigational Site | Lee's Summit | Missouri | 64064 | — |
| GSK Investigational Site | Mexico | Missouri | 65265-3726 | — |
| GSK Investigational Site | Brooklyn | New York | 11206 | — |
| GSK Investigational Site | East Setauket | New York | 11733-9292 | — |
| GSK Investigational Site | Great Neck | New York | 11021 | — |
| GSK Investigational Site | Lake Success | New York | 11042 | — |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7080 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28209 | — |
| GSK Investigational Site | Durham | North Carolina | 27710 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27612 | — |
| GSK Investigational Site | Columbus | Ohio | 43215 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74135 | — |
| GSK Investigational Site | Portland | Oregon | 97225 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | — |
| GSK Investigational Site | Germantown | Tennessee | 38138 | — |
| GSK Investigational Site | Nashville | Tennessee | 37212-1610 | — |
| GSK Investigational Site | Ogden | Utah | 84405 | — |
| GSK Investigational Site | Christiansburg | Virginia | 24073 | — |
| GSK Investigational Site | Danville | Virginia | 24541 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
| GSK Investigational Site | Richmond | Virginia | 23249 | — |
| GSK Investigational Site | Seattle | Washington | 98101 | — |
| GSK Investigational Site | Seattle | Washington | 98195 | — |
| GSK Investigational Site | Madison | Wisconsin | 53792 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 189 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01318993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2017 · Synced Oct 31, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01318993 live on ClinicalTrials.gov.