Efficacy of Gralise® for Chronic Pelvic Pain
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Irritable Bowel Syndrome Ulcerative Colitis Interstitial Cystitis Prostatitis Pelvic Pain |
Drug: Gralise |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Gralise® for Chronic Pelvic Pain |
- Pain Numeric Rating Scale collected 3 times a day [ Time Frame: fifteen week period ] [ Designated as safety issue: No ]Our primary outcome will be 'worst pain of the day' and spontaneous pain averages by Numeric Rating Scale (NRS) collected three times a day. This data will be captured using an electronic diary.
- Sensory Testing [ Time Frame: 4 visits over 15 weeks ] [ Designated as safety issue: No ]Pressure Pain Threshold, Pinprick, Mechanical Windup
- McGill Pain Questionnaire - Short Form [ Time Frame: 4 Visits over a 15 week period ] [ Designated as safety issue: No ]Self-report questionnaires
- Pain Anxiety Symptoms Scale [ Time Frame: 4 Visits over an 8 week period ] [ Designated as safety issue: No ]Self-report questionnaires.
- Pain Disability Index [ Time Frame: 4 visits over an 8 week period ] [ Designated as safety issue: No ]Self-report questionnaires
- Center for Epidemiologic Studies Depression Scale [ Time Frame: 4 visits over 15 week period ] [ Designated as safety issue: No ]Self-report questionnaires
- Pelvic Floor Impact Questionnaire [ Time Frame: 4 visits over 15 weeks ] [ Designated as safety issue: No ]Self-report questionnaires
- Patient Global Impression of Change [ Time Frame: 4 Visits over 15 weeks ] [ Designated as safety issue: No ]Self-report questionnaires
- Patient Global Impression of Function [ Time Frame: 4 visits over 15 weeks ] [ Designated as safety issue: No ]Self-report questionnaires
| Enrollment: | 11 |
| Study Start Date: | August 2012 |
| Study Completion Date: | June 2014 |
| Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Sugar pill
Subjects may receive a pill with no medicine.
|
|
|
Active Comparator: Gralise
Gralise (a long acting gabapentinoid)
|
Drug: Gralise
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).
Other Name: Gabapentin
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01678911
| United States, Illinois | |
| Rehabilitation Institute Of Chicago | |
| Chicago, Illinois, United States, 60611 | |
| Principal Investigator: | Norman Harden, MD | Rehabilitation Institute of Chicago |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Norman Harden, Director, Center for Pain Studies, Rehabilitation Institute of Chicago |
| ClinicalTrials.gov Identifier: | NCT01678911 History of Changes |
| Other Study ID Numbers: | RIC_Dep_CPP_2012 |
| Study First Received: | August 31, 2012 |
| Last Updated: | August 1, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rehabilitation Institute of Chicago:
|
Pelvic Pain Chronic Pelvic Pain Irritable Bowel Syndrome IBS Ulcerative Colitis |
UC Interstitial Cystitis IC Prostatitis Pain |
Additional relevant MeSH terms:
|
Colitis, Ulcerative Cystitis, Interstitial Irritable Bowel Syndrome Pelvic Pain Colitis Colonic Diseases Colonic Diseases, Functional Cystitis Digestive System Diseases |
Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Pain Signs and Symptoms Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on March 02, 2015