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Study ended due to difficulties in recruitment and low enrollment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then Gralise | Placebo Comparator | Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2. |
|
| Gralise then Placebo | Active Comparator | Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gralise | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 Visits over a 15 week period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 Visits over an 8 week period |
| Pain Disability Index |
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Inclusion Criteria:
Exclusion Criteria:
Female subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Norman Harden, MD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitation Institute Of Chicago | Chicago | Illinois | 60611 | United States |
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| Label | URL |
|---|---|
| Site Contact Info | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, Then Gralise | Subjects may receive a pill with no medicine. |
| FG001 | Gralise Then Placebo | Gralise (a long acting gabapentinoid) 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All randomized subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 4 Visits over a 15 week period |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugar Pill | Subjects may receive a pill with no medicine. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | General disorders |
This study was terminated early due to low recruitment. Therefore, the data presented represents a very small sample, with low 'n's in each group. The data tables represent all available data for the small sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of the Center for Pain Studies | Rehabilitation Institute of Chicago | 312.238.5654 | centerforpainstudies@ric.org |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003093 | Colitis, Ulcerative |
| D018856 | Cystitis, Interstitial |
| D011472 | Prostatitis |
| D017699 | Pelvic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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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.
| 4 visits over an 8 week period |
| 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. | 4 visits over 15 week period |
| 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. | 4 Visits over 15 weeks |
| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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. | Posted | Mean | Standard Deviation | units on the PASS scale | 4 Visits over an 8 week period |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 4 visits over an 8 week period |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 4 visits over 15 week period |
|
|
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| 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. | Posted | Number | participants | 4 Visits over 15 weeks |
|
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| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Gralise | Gralise (a long acting gabapentinoid) 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). | 0 | 5 | 2 | 5 |
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| D004066 | Digestive System Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D015212 | Inflammatory Bowel Diseases |
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| worse after intervention 1 |
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| improved after intervention 2 |
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| no change after intervention 2 |
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| worse after intervention 2 |
|