Efficacy of Gralise® for Chronic Pelvic Pain
| Status: | Completed |
|---|---|
| Conditions: | Colitis, Irritable Bowel Syndrome (IBS), Other Indications, Women's Studies, Gastrointestinal, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Other, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/5/2014 |
| Start Date: | August 2012 |
| End Date: | June 2014 |
| Contact: | Sara Connolly |
| Email: | sconnolly@ric.org |
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.
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.
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.
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.
Inclusion Criteria:
- 18 years of age and older
- English speaking
- able to give consent
- willing to use electronic diary during entire length of the study
- has 'chronic' pelvic pain
- Meets one of the following diagnostic criteria for one of the following: Irritable
Bowel Syndrome (IBS) Ulcerative Colitis (UC), Interstitial Cystitis (IC), and
Prostatitis
Exclusion Criteria:
- allergic to gabapentin or inactive ingredients
- taking gabapentinoids (i.e. gabapentin or pre-gabalin)
- with severe or unmanaged psychiatric disturbance (at PI discretion)
- with severe ongoing or unaddressed medical conditions (esp. Renal or Hepatic disease,
uncontrolled hypertension), rheumatologic disease, narrow angle glaucoma,
hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention.
- who plan to change their therapeutic regimen during the course of the trial (e.g.
start physical therapy, massage, medications, injections, etc.)
- with acute pain
Female subjects:
- pregnant or plan to become pregnant
- gave birth within the last 6 months
- breastfeeding
- episodic visceral pain (e.g. endometriosis)
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