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
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Ulcerative Colitis
Interstitial Cystitis
Prostatitis
Pelvic Pain
Drug: Gralise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Gralise® for Chronic Pelvic Pain

Resource links provided by NLM:


Further study details as provided by Rehabilitation Institute of Chicago:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 11
Study Start Date: August 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678911

Locations
United States, Illinois
Rehabilitation Institute Of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Rehabilitation Institute of Chicago
Investigators
Principal Investigator: Norman Harden, MD Rehabilitation Institute of Chicago
  More Information

Additional Information:
No publications provided

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
Study First Received: August 31, 2012
Results First Received: May 20, 2015
Last Updated: June 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by 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, Ulcerative
Cystitis
Cystitis, Interstitial
Irritable Bowel Syndrome
Pelvic Pain
Prostatitis
Colitis
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Genital Diseases, Male
Inflammatory Bowel Diseases
Intestinal Diseases
Pain
Prostatic Diseases
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Gabapentin
Analgesics
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 03, 2015