Efficacy of Gralise® for Chronic Pelvic Pain
TerminatedPhase 4NCT01678911
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Efficacy of Gralise® for Chronic Pelvic Pain
- Conditions
- Irritable Bowel Syndrome
- Ulcerative Colitis
- Interstitial Cystitis
- Prostatitis
- Pelvic Pain
- Interventions
- Drug: Gralise
- Sponsor
- Shirley Ryan AbilityLab
- Start date
- 2012-08
- Primary completion
- 2014-03
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01678911