Efficacy of Gralise® for Chronic Pelvic Pain
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ClinicalTrials.gov Identifier: NCT01678911 |
Recruitment Status
:
Terminated
(Study ended due to difficulties in recruitment and low enrollment.)
First Posted
: September 5, 2012
Results First Posted
: June 29, 2015
Last Update Posted
: June 29, 2015
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Condition or disease | Intervention/treatment | Phase |
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Irritable Bowel Syndrome Ulcerative Colitis Interstitial Cystitis Prostatitis Pelvic Pain | Drug: Gralise | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 11 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Gralise® for Chronic Pelvic Pain |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo then Gralise
Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
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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
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Active Comparator: Gralise then Placebo
Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
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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
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- McGill Pain Questionnaire - Short Form [ Time Frame: 4 Visits over a 15 week period ]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).
- Pain Anxiety Symptoms Scale [ Time Frame: 4 Visits over an 8 week period ]The Pain Anxiety Symptoms Scale (PASS) is an anxiety scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.
- Pain Disability Index [ Time Frame: 4 visits over an 8 week period ]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.
- Center for Epidemiologic Studies Depression Scale [ Time Frame: 4 visits over 15 week period ]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.
- Patient Global Impression of Change [ Time Frame: 4 Visits over 15 weeks ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678911
United States, Illinois | |
Rehabilitation Institute Of Chicago | |
Chicago, Illinois, United States, 60611 |
Principal Investigator: | Norman Harden, MD | Shirley Ryan AbilityLab |
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 |
First Posted: | September 5, 2012 Key Record Dates |
Results First Posted: | June 29, 2015 |
Last Update Posted: | June 29, 2015 |
Last Verified: | June 2015 |
Keywords provided by Dr. Norman Harden, 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 Ulcer Colitis, Ulcerative Irritable Bowel Syndrome Pelvic Pain Cystitis Cystitis, Interstitial Prostatitis Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |
Colonic Diseases, Functional Pain Neurologic Manifestations Signs and Symptoms Urinary Bladder Diseases Urologic Diseases Prostatic Diseases Genital Diseases, Male Gabapentin gamma-Aminobutyric Acid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anticonvulsants |