Efficacy of Gralise® for Chronic Pelvic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Gralise® for Chronic Pelvic Pain

Conditions
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Irritable Bowel Syndrome, Ulcerative Colitis, Interstitial Cystitis, Prostatitis, Pelvic Pain

Intervention / Treatment
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* Drug: Gralise


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo then Gralise<br>Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2. | Drug: Gralise<br>* Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of wash-out before repeating the above procedure for the other arm of the study (placebo or medication).<br>* Other names: Gabapentin;|
| Active Comparator: Gralise then Placebo<br>Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2. | Drug: Gralise<br>* Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of wash-out before repeating the above procedure for the other arm of the study (placebo or medication).<br>* Other names: Gabapentin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| McGill Pain Questionnaire - Short Form | The MPQ-SF is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are averaged to compute a total score. The scale ranges from 0-10 (0=no pain, 10=the most pain). | 4 Visits over a 15 week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Anxiety Symptoms Scale | The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety. | 4 Visits over an 8 week period | 
| Pain Disability Index | The PDI is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability. | 4 visits over an 8 week period | 
| Center for Epidemiologic Studies Depression Scale | The CES-D 10 is a 10-item questionnaire that has been validated for the assessment of depressive symptomatology. The Depression Scale is a scale with a sum score from 0 - 30, where 0 = no Depression and 30 = the most Depression. | 4 visits over 15 week period | 
| Patient Global Impression of Change | Patient Global Impression of Change is a self-report questionnaire on which patient indicate their perceived impression of change since the start of the study given the following options: Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, or Very much Worse. | 4 Visits over 15 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic Pain, Chronic Pelvic Pain, Irritable Bowel Syndrome, IBS, Ulcerative Colitis, UC, Interstitial Cystitis, IC, Prostatitis, Pain