Efficacy of Gralise® for Chronic Pelvic Pain
Condition: Irritable Bowel Syndrome; Ulcerative Colitis; Interstitial Cystitis; Prostatitis; Pelvic Pain
MeSH terms: Colitis; Colitis, Ulcerative; Irritable Bowel Syndrome; Cystitis; Cystitis, Interstitial; Prostatitis; Pelvic Pain
Intervention: Gralise
Intervention description: 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).
Intervention MeSH terms: Gabapentin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pelvic Pain; Chronic Pelvic Pain; Irritable Bowel Syndrome; IBS; Ulcerative Colitis; UC; Interstitial Cystitis; IC; Prostatitis; Pain

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.
    

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)