Clinical trial NCT01678911: Efficacy of Gralise® for Chronic Pelvic Pain
Official title: Efficacy of Gralise® for Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Ulcerative Colitis
Interstitial Cystitis
Prostatitis
Pelvic Pain
Keywords: Pelvic Pain
Chronic Pelvic Pain
Irritable Bowel Syndrome
IBS
Ulcerative Colitis
UC
Interstitial Cystitis
IC
Prostatitis
Pain
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: McGill Pain Questionnaire - Short Form
timeFrame: 4 Visits over a 15 week period
Secondary outcomes:
measure: Pain Anxiety Symptoms Scale
timeFrame: 4 Visits over an 8 week period
measure: Pain Disability Index
timeFrame: 4 visits over an 8 week period
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: 4 visits over 15 week period
measure: Patient Global Impression of Change
timeFrame: 4 Visits over 15 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute Of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Norman Harden, MD
role: PRINCIPAL_INVESTIGATOR
References: