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NCT03494764 · ClinicalTrials.gov registry record · Phase 2
Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares
A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
NCT03494764 is a Phase 2 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 39 participants.
The verdict
NCT03494764, a Phase 2 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
Study Summary
Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary based on disease activity and target various aspects of the inflammatory cascade. Options include: anti-inflammatory drugs (mesalamine), immunosuppressive or modulatory medications (corticosteroids, thiopurines, cyclosporine) and biologic agents (Anti-TNF). Disease severity can be wide ranging, and nearly 25% of UC patients are hospitalized for acute severe disease. Of these patients, 30% will undergo colectomy after the acute episode, a quarter of which will experience post-operative complications. Although there has been great progress in treatment of UC over the past decade, even with the anti-TNF agent infliximab, the one-year remission rate for patients not responding to conservative management is barely 20%. Furthermore, corticosteroids have significant long-term consequences and immune suppressive drugs such as 6-mercaptopurine, azathioprine and infliximab have been associated with serious adverse events including life-threatening infections and lymphomas. With growing evidence that the pathogenesis of UC is multi-factorial and involves a complex interaction of genetic and environmental factors, newer treatment modalities are being evaluated to target the mucosal immune response and mucosal inflammatory regulatory system. Hyperbaric oxygen offers a promising new treatment option since it targets both tissue hypoxia and inflammation. Recent small scales studies evaluating the impact of hyperbaric oxygen treatment in acute ulcerative colitis flares demonstrated improved outcomes. The mechanisms underlying the improvement are not known. In this study, we will treat ulcerative colitis flares with hyperbaric oxygen and measure changes in both markers of tissue hypoxia and inflammation. We hypot
Interventions
- OTHER Hyperbaric Oxygen Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-09-07 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03494764
The ClinicalTrials.gov registry entry for NCT03494764 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 427 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hyperbaric Oxygen Therapy is the first listed.
NCT03494764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03494764 about?
NCT03494764 is a clinical study titled "Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares". Ulcerative colitis (UC) is a chronic inflammatory bowel disease associated with recurrent mucosal inflammation. Clinically, the disease is characterized by bloody diarrhea, abdominal pain, and constitutional symptoms such as fever and weight loss. Treatment strategies vary based on disease activity ...
What is the current status of trial NCT03494764?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2017-09-07. Estimated completion is 2020-03-31.
What interventions are being tested in trial NCT03494764?
The interventions under investigation include: Hyperbaric Oxygen Therapy (OTHER).
Who is sponsoring clinical trial NCT03494764?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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