Efficacy of Gralise® for Chronic Pelvic Pain

Shirley Ryan AbilityLab

Status and phase: Terminated; Phase 4

Conditions: Irritable Bowel Syndrome; Prostatitis; Interstitial Cystitis; Pelvic Pain; Ulcerative Colitis

Treatments: Drug: Gralise

Study type: Interventional

Funder types: Other

Identifiers

NCT01678911

RIC_Dep_CPP_2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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11 participants in 2 patient groups, including a placebo group

Placebo then Gralise

Placebo Comparator group

Description:

Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.

Treatment:

Drug: Gralise

Gralise then Placebo

Active Comparator group

Description:

Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.

Treatment:

Drug: Gralise