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Efficacy of Gralise® for Chronic Pelvic Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dr. Norman Harden, Shirley Ryan AbilityLab

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Results First Submitted Date  ICMJE May 20, 2015
Results First Posted Date  ICMJE June 29, 2015
Last Update Posted Date June 29, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
Pain Numeric Rating Scale collected 3 times a day [ Time Frame: fifteen week period ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
  • Sensory Testing [ Time Frame: 4 visits over 15 weeks ]
    Pressure Pain Threshold, Pinprick, Mechanical Windup
  • McGill Pain Questionnaire - Short Form [ Time Frame: 4 Visits over a 15 week period ]
    Self-report questionnaires
  • Pain Anxiety Symptoms Scale [ Time Frame: 4 Visits over an 8 week period ]
    Self-report questionnaires.
  • Pain Disability Index [ Time Frame: 4 visits over an 8 week period ]
    Self-report questionnaires
  • Center for Epidemiologic Studies Depression Scale [ Time Frame: 4 visits over 15 week period ]
    Self-report questionnaires
  • Pelvic Floor Impact Questionnaire [ Time Frame: 4 visits over 15 weeks ]
    Self-report questionnaires
  • Patient Global Impression of Change [ Time Frame: 4 Visits over 15 weeks ]
    Self-report questionnaires
  • Patient Global Impression of Function [ Time Frame: 4 visits over 15 weeks ]
    Self-report questionnaires
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Gralise® for Chronic Pelvic Pain
Official Title  ICMJE Efficacy of Gralise® for Chronic Pelvic 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Irritable Bowel Syndrome
  • Ulcerative Colitis
  • Interstitial Cystitis
  • Prostatitis
  • Pelvic Pain
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 1, 2014)
11
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
36
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678911
Other Study ID Numbers  ICMJE RIC_Dep_CPP_2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Norman Harden, Shirley Ryan AbilityLab
Study Sponsor  ICMJE Shirley Ryan AbilityLab
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Norman Harden, MD Shirley Ryan AbilityLab
PRS Account Shirley Ryan AbilityLab
Verification Date June 2015

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