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Efficacy of Gralise® for Chronic Pelvic Pain

This study has been terminated.
(Study ended due to difficulties in recruitment and low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Dr. Norman Harden, Rehabilitation Institute of Chicago
ClinicalTrials.gov Identifier:
NCT01678911
First received: August 31, 2012
Last updated: June 26, 2015
Last verified: June 2015

August 31, 2012
June 26, 2015
August 2012
March 2014   (final data collection date for primary outcome measure)
McGill Pain Questionnaire - Short Form [ Time Frame: 4 Visits over a 15 week period ] [ Designated as safety issue: No ]
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 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.
Complete list of historical versions of study NCT01678911 on ClinicalTrials.gov Archive Site
  • Pain Anxiety Symptoms Scale [ Time Frame: 4 Visits over an 8 week period ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
  • 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
Not Provided
Not Provided
 
Efficacy of Gralise® for Chronic Pelvic Pain
Efficacy of Gralise® for Chronic Pelvic Pain
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Irritable Bowel Syndrome
  • Ulcerative Colitis
  • Interstitial Cystitis
  • Prostatitis
  • Pelvic Pain
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
  • 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.
    Intervention: Drug: Gralise
  • 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.
    Intervention: Drug: Gralise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
June 2014
March 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01678911
RIC_Dep_CPP_2012
Yes
Not Provided
Not Provided
Dr. Norman Harden, Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
Not Provided
Principal Investigator: Norman Harden, MD Rehabilitation Institute of Chicago
Rehabilitation Institute of Chicago
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP