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NCT02144350 · ClinicalTrials.gov registry record · Phase 2
Hyperbaric Oxygen for Ulcerative Colitis
A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT02144350: Clinical Trial Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT02144350 is a Phase 2 study that was terminated before completion, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02144350, a Phase 2 study, was terminated before completion, sponsored by Dartmouth-Hitchcock Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on clinical response/remission and serum and mucosal inflammatory markers. The investigators expect that hyperbaric oxygen therapy will improve patient responsiveness to steroids and avoid progression to second line therapy during hospitalization.
Primary Outcome
Impact of hyperbaric oxygen therapy on clinical response/remission to medical therapy as measured by the partial Mayo score at study day 5. Clinical remission will be defined as a partial Mayo score of less than or equal to 2 with no individual sub-score exceeding 1 point. Clinical response will be defined as a decrease in partial Mayo score greater than or equal to 2 points with a decrease in rectal bleeding sub-score of greater than or equal to 1 point, or an absolute rectal bleeding sub-score
Interventions
- PROCEDURE Hyperbaric oxygen
- PROCEDURE Sham Hyperbaric Air
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
Why NCT02144350 stopped before completion
NCT02144350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Hyperbaric oxygen is the first listed.
NCT02144350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02144350 about?
NCT02144350 is a clinical study titled "Hyperbaric Oxygen for Ulcerative Colitis". The investigators aim to prospectively study the feasibility and clinical impact of hyperbaric oxygen therapy in acute hospitalized moderate to severe ulcerative colitis flares as an adjunct to standard medical treatment. Specifically, we will investigate the impact of hyperbaric oxygen therapy on c...
What is the current status of trial NCT02144350?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2013-08. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02144350?
The interventions under investigation include: Hyperbaric oxygen (PROCEDURE), Sham Hyperbaric Air (PROCEDURE).
Who is sponsoring clinical trial NCT02144350?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02144350's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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