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Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories

NCT04469686

CompletedPhase 3

Sponsor: Cristcot HCA LLC

Conditions: Ulcerative Proctitis

Interventions: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator, Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator, Twice daily placebo suppository administered with Sephure applicator

Countries: United States, Bulgaria, China, Denmark, France, Georgia, Germany, India

A randomized, multi-center, double-blind, three arm placebo-controlled study in male and non-pregnant, non-lactating female subjects aged 18 years to examine the safety and efficacy of two dosing regimens of hydrocortisone acetate 90 mg suppository administered with the Sephure suppository applicator for the treatment of ulcerative colitis of the rectum.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Male or non pregnant, non lactating females aged 18 years and older.
* Able to provide informed consent.
* Subjects with a confirmed diagnosis of active UC of the rectum, extending no more than 15 centimeters (cm) (5.9 inches) proximal to the anal verge as assessed by colonoscopy performed at Visit 2. Note: Subjects may have a history of more extensive UC (e.g., pancolitis), but have active disease only in the rectum at the time of enrollment.
* Modified Mayo sub score for stool frequency of 1-3.
* Modified Mayo sub score for rectal bleeding of 0-2.
* Modified Mayo endoscopic sub score of 2-3.
* Total Modified Mayo Score (without physician global assessment) of 4-8.

Exclusion Criteria:

* History or current diagnosis of bacterial or other infectious colitis, radiation enteritis and radiation proctitis, Crohn's disease, collagenous colitis and indeterminate colitis.
* Prior gastrointestinal surgery except appendectomy, cholecystectomy, and hernia.
* Concomitant active lower gastrointestinal disease (except Irritable Bowel Syndrome) or distortion of intestinal anatomy.
* Bleeding hemorrhoids at the time of enrollment.
* Acute diverticulitis at the time of enrollment.
* Acute or chronic pancreatitis at the time of enrollment.
* Unmanaged celiac disease at the time of enrollment.
* Positive stool test for enteric pathogens, Clostridium difficile, or presence of ova and parasites.
* Taking a prohibited medication.
Locations (189)
  • Huntsville, Alabama, United States
  • Apple Valley, California, United States
  • Camarillo, California, United States
  • El Cajon, California, United States
  • Lancaster, California, United States
  • Los Angeles, California, United States
  • Newport Beach, California, United States
  • Northridge, California, United States
  • San Diego, California, United States
  • Kissimmee, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Naples, Florida, United States
  • Orange City, Florida, United States
  • Orlando, Florida, United States
  • Plantation, Florida, United States
  • Tampa, Florida, United States
  • Johns Creek, Georgia, United States
  • Northbrook, Illinois, United States
  • Waterloo, Iowa, United States
  • Lafayette, Louisiana, United States
  • Chesterfield, Michigan, United States
  • Farmington Hills, Michigan, United States
  • Troy, Michigan, United States
  • East Orange, New Jersey, United States
  • Carmel, New York, United States
  • High Point, North Carolina, United States
  • + 159 more on CT.gov