Interstitial Cystitis, Irritable Bowel Syndrome, Pelvic Pain, Prostatitis, Ulcerative Colitis
Conditions
Keywords
Pelvic Pain, Chronic Pelvic Pain, Irritable Bowel Syndrome, IBS, Ulcerative Colitis, UC, Interstitial Cystitis, IC, Prostatitis, Pain
Brief 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.
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.
Interventions
DRUGGralise
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).
Sponsors
Shirley Ryan AbilityLab
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| McGill Pain Questionnaire - Short Form | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Anxiety Symptoms Scale | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
11 Subjects enrolled in the study and started a single-blind placebo lead-in period. Of those, 5 were randomized. 6 subjects did not continue and were either lost to follow-up, chose not to continue, or exhibited a large placebo response and no longer met the criteria to continue in the study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All randomized subjects | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 44.6 years STANDARD_DEVIATION 13.2 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
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).
Time frame: 4 Visits over a 15 week period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Gralise | McGill Pain Questionnaire - Short Form | change from baseline after intervention 1 | -0.34 units on a scale | Standard Deviation 1.78 |
| Placebo Then Gralise | McGill Pain Questionnaire - Short Form | change from baseline after intervention 2 | 1.05 units on a scale | Standard Deviation 0.45 |
| Gralise Then Placebo | McGill Pain Questionnaire - Short Form | change from baseline after intervention 1 | .04 units on a scale | Standard Deviation 0 |
| Gralise Then Placebo | McGill Pain Questionnaire - Short Form | change from baseline after intervention 2 | .41 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 4 visits over 15 week period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Gralise | Center for Epidemiologic Studies Depression Scale | change after intervention 1 | 4.5 units on a scale | Standard Deviation 5.7 |
| Placebo Then Gralise | Center for Epidemiologic Studies Depression Scale | change after intervention 2 | 7 units on a scale | Standard Deviation 2.8 |
| Gralise Then Placebo | Center for Epidemiologic Studies Depression Scale | change after intervention 1 | -1 units on a scale | Standard Deviation 0 |
| Gralise Then Placebo | Center for Epidemiologic Studies Depression Scale | change after intervention 2 | 0 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 4 Visits over an 8 week period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Gralise | Pain Anxiety Symptoms Scale | mean change after intervention 1 | -5.8 units on the PASS scale | Standard Deviation 18 |
| Placebo Then Gralise | Pain Anxiety Symptoms Scale | mean change after intervention 2 | 9.0 units on the PASS scale | Standard Deviation 22.6 |
| Gralise Then Placebo | Pain Anxiety Symptoms Scale | mean change after intervention 1 | -4 units on the PASS scale | Standard Deviation 0 |
| Gralise Then Placebo | Pain Anxiety Symptoms Scale | mean change after intervention 2 | -5 units on the PASS scale | Standard Deviation 0 |
Secondary
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.
Time frame: 4 visits over an 8 week period
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Then Gralise | Pain Disability Index | change after intervention 1 | 4.8 units on a scale | Standard Deviation 13.9 |
| Placebo Then Gralise | Pain Disability Index | change after intervention 2 | 19 units on a scale | Standard Deviation 4.2 |
| Gralise Then Placebo | Pain Disability Index | change after intervention 1 | 10 units on a scale | Standard Deviation 0 |
| Gralise Then Placebo | Pain Disability Index | change after intervention 2 | 14 units on a scale | Standard Deviation 0 |
Secondary
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.
Time frame: 4 Visits over 15 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Then Gralise | Patient Global Impression of Change | no change after intervention 1 | 0 participants |
| Placebo Then Gralise | Patient Global Impression of Change | improved after intervention 2 | 1 participants |
| Placebo Then Gralise | Patient Global Impression of Change | improved after intervention 1 | 3 participants |
| Placebo Then Gralise | Patient Global Impression of Change | no change after intervention 2 | 1 participants |
| Placebo Then Gralise | Patient Global Impression of Change | worse after intervention 1 | 1 participants |
| Placebo Then Gralise | Patient Global Impression of Change | worse after intervention 2 | 0 participants |
| Gralise Then Placebo | Patient Global Impression of Change | worse after intervention 2 | 1 participants |
| Gralise Then Placebo | Patient Global Impression of Change | improved after intervention 1 | 0 participants |
| Gralise Then Placebo | Patient Global Impression of Change | no change after intervention 1 | 1 participants |
| Gralise Then Placebo | Patient Global Impression of Change | worse after intervention 1 | 0 participants |
| Gralise Then Placebo | Patient Global Impression of Change | improved after intervention 2 | 0 participants |
| Gralise Then Placebo | Patient Global Impression of Change | no change after intervention 2 | 0 participants |