Study Stopped
Study ended due to difficulties in recruitment and low enrollment.
Efficacy of Gralise® for Chronic Pelvic Pain
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 31, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 29, 2015
CompletedJune 29, 2015
June 1, 2015
1.6 years
August 31, 2012
May 20, 2015
June 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
Pain Anxiety Symptoms Scale
4 Visits over an 8 week period
Pain Disability Index
4 visits over an 8 week period
Center for Epidemiologic Studies Depression Scale
4 visits over 15 week period
Patient Global Impression of Change
4 Visits over 15 weeks
Study Arms (2)
Placebo then Gralise
PLACEBO COMPARATORSubjects 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 COMPARATORSubjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Institute Of Chicago
Chicago, Illinois, 60611, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- Director of the Center for Pain Studies
- Organization
- Rehabilitation Institute of Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Harden, MD
Shirley Ryan AbilityLab
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Pain Studies
Study Record Dates
First Submitted
August 31, 2012
First Posted
September 5, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
June 29, 2015
Results First Posted
June 29, 2015
Record last verified: 2015-06