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NCT01678911 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Gralise® for Chronic Pelvic Pain
A Phase 4 study, sponsored by Shirley Ryan AbilityLab.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT01678911: Clinical Trial Phase 4 study, sponsored by Shirley Ryan AbilityLab.
NCT01678911 is a Phase 4 study that was terminated before completion, run by Shirley Ryan AbilityLab. The registered enrollment target is 11 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01678911, a Phase 4 study, was terminated before completion, sponsored by Shirley Ryan AbilityLab.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study 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.
Primary Outcome
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).
Interventions
- DRUG Gralise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2012-08 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
Why NCT01678911 stopped before completion
NCT01678911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Gralise is the first listed.
NCT01678911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01678911 about?
NCT01678911 is a clinical study titled "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 ...
What is the current status of trial NCT01678911?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2012-08. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01678911?
The interventions under investigation include: Gralise (DRUG).
Who is sponsoring clinical trial NCT01678911?
This trial is sponsored by Shirley Ryan AbilityLab, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01678911's enrollment target sits among peer trials
11 1931st of 2000 higher than 61 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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