ClinicalTrials.gov
Cure8 trial brief
Why This Matters
This trial tested a rectal hydrocortisone formulation specifically for ulcerative proctitis, a form of ulcerative colitis limited to the rectum. If effective and safe, a local steroid suppository could offer targeted treatment with potentially fewer systemic effects than oral steroids.
Who Should Pay Attention
Adults with ulcerative proctitis or distal ulcerative colitis, gastroenterologists and IBD clinicians, clinical researchers studying rectal therapies, and patients interested in topical steroid options.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 3
Enrollment200 participants
Study statusCompleted
Source depthTrial registry record
What To Know
This is a completed Phase 3 randomized, double-blind, placebo-controlled trial testing hydrocortisone acetate 90 mg rectal suppositories (administered with a Sephure applicator) for active ulcerative proctitis.
The study compared two dosing regimens (twice daily and once daily) versus placebo over 28 days, with clinical remission at Day 29 as the primary endpoint defined by a Modified Mayo score.
The trial enrolled adults with active ulcerative colitis limited to the rectum (≤15 cm from the anal verge) and excluded patients with Crohn's disease, infectious colitis, or other specified conditions. Planned enrollment was about 200 subjects across multiple US sites.
Because this is the clinicaltrials.gov record (trial-status: COMPLETED), the entry describes study design, eligibility, interventions, and registered primary outcome but does not provide results in this record. For outcome data, look for a results posting on ClinicalTrials.gov, a peer-reviewed publication, or sponsor communications.
If you are considering rectal steroid therapy, discuss options with your clinician; this record does not replace medical advice.
Keep In Mind
This record is a trial registry entry marked COMPLETED but does not include trial results or summary data. Do not assume benefit or safety from the registry alone; await posted results or peer-reviewed reporting. The study specifically excluded Crohn's disease and other causes of proctitis.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorCristcot HCA LLC
Trial IDNCT04469686
Study typeInterventional
Trial phasePhase 3
Enrollment200 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 6, 2026, 12:00 AM
Content availableTrial registry record
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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