Ignite Creation Date:
2024-05-06 @ 12:51 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01678911
Status:
TERMINATED
Last Update Posted:
2015-06-29
First Post:
2012-08-31
Brief Title:
Efficacy of Gralise for Chronic Pelvic Pain
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Efficacy of Gralise for Chronic Pelvic Pain
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study ended due to difficulties in recruitment and low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is done to investigate the pain relieving effects of the study drug Gralise a novel long acting gabapentinoid for people who experience chronic pelvic pain Subjects with Irritable Bowel Syndrome Interstitial Cystitis Ulcerative Colitis and Prostatitis will be recruited The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain This is a phase IV study done to study the safety and effectiveness of the drug At this point the drug has been approved by the Food and Drug Administration and has been reported to be well tolerated and effective in the treatment of various chronic pain conditions particularly in neuropathic pain About 36 subjects will take part in this study
Detailed Description:
As a participant in this study you will be asked to come to the Rehabilitation Institute of Chicago RIC Center for Pain Studies 446 E Ontario St Suite 1011 Chicago IL 60611 Your part in this study will last for 15 weeks and will involve 4 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day
If you are in this study you will be placed in one of two study groups one group will receive the study drug followed by a placebo and the second group will receive a placebo followed by the study drug The amount of weeks on placebo versus the study drug will not be equal You will be assigned a study group by chance using a process similar to the flip of a coin This process is called randomization Neither you nor the study staff will select the group you will be in However if you have a medical emergency we can get this information A placebo looks like the study drug but is an inactive substance that has no medication Researchers use a placebo to see if the study drug works better or is safer than not taking anything
If you are in this study you will be placed in one of two study groups one group will receive the study drug followed by a placebo and the second group will receive a placebo followed by the study drug The amount of weeks on placebo versus the study drug will not be equal You will be assigned a study group by chance using a process similar to the flip of a coin This process is called randomization Neither you nor the study staff will select the group you will be in However if you have a medical emergency we can get this information A placebo looks like the study drug but is an inactive substance that has no medication Researchers use a placebo to see if the study drug works better or is safer than not taking anything
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None