Ulcerative Proctitis
Conditions
Brief summary
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.
Detailed description
Hydrocortisone acetate 90 mg or placebo will be administered as a rectal suppository with a Sephure suppository applicator. Two arms of the study will receive different dosage regimens of hydrocortisone acetate, and the third arm will receive placebo. All subjects will administer the study drug twice a day; once in the morning and once in the evening for 28 days. The study population will consist of male and non pregnant, non lactating females aged 18 years and older with a confirmed diagnosis of active ulcerative colitis of the rectum.
Interventions
COMBINATION_PRODUCTTwice daily placebo suppository administered with Sephure applicator
Twice daily placebo suppository administered with Sephure applicator
COMBINATION_PRODUCTTwice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
COMBINATION_PRODUCTOnce daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
Sponsors
Cristcot HCA LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Remission | 29 days | The primary efficacy endpoint was specified as the between-treatment group (HCA Suppository 90 mg bid versus placebo and HCA Suppository 90 mg qd versus placebo) difference in the proportion of subjects with clinical remission at the End of Treatment visit (Day 29). Clinical remission was defined as a Modified Mayo Total Score of 0 to 2, with stool frequency subscore of 0 or 1 (minimum 1 point decrease from baseline), rectal bleeding subscore of 0, and endoscopic subscore of 0 or 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Stool Frequency | 29 days | Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency to assess the change in stool frequency from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15). |
| Rectal Bleeding | 29 days | Rectal Bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to assess the change in rectal bleeding in active treatment groups vs. placebo group from Baseline (Day 1) to End of Treatment (Day 29) and from Baseline (Day 1) to Follow-up (Day 15). |
Countries
Bulgaria, China, Denmark, France, Georgia, Germany, India, Italy, Jordan, Lebanon, Libya, Moldova, Philippines, Poland, Romania, Russia, Saudi Arabia, South Africa, Spain, Turkey (Türkiye), Ukraine, United States, Vietnam
Contacts
STUDY_DIRECTORJennifer Davagian
Cristcot LLC
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 15.19 |
| Disease History by Study Treatment Extensive colitis | 2 Participants |
| Disease History by Study Treatment Left sided colitis | 11 Participants |
| Disease History by Study Treatment Pancolitis | 10 Participants |
| Disease History by Study Treatment Proctitis | 41 Participants |
| Disease History by Study Treatment Proctosigmoiditis | 11 Participants |
| Modified Mayo Score Total Score: 3 | 2 Participants |
| Modified Mayo Score Total Score: 4 | 36 Participants |
| Modified Mayo Score Total Score: 5 | 18 Participants |
| Modified Mayo Score Total Score: 6 | 20 Participants |
| Modified Mayo Score Total Score: 7 | 14 Participants |
| Modified Mayo Score Total Score: 8 | 7 Participants |
| Race/Ethnicity, Customized American Indian or Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized White | 52 Participants |
| Region of Enrollment Bulgaria | 1 Participants |
| Region of Enrollment Denmark | 3 Participants |
| Region of Enrollment France | 4 Participants |
| Region of Enrollment Georgia | 2 Participants |
| Region of Enrollment Germany | 1 Participants |
| Region of Enrollment Hong Kong | 1 Participants |
| Region of Enrollment India | 9 Participants |
| Region of Enrollment Italy | 1 Participants |
| Region of Enrollment Jordan | 3 Participants |
| Region of Enrollment Lebanon | 4 Participants |
| Region of Enrollment Moldova | 6 Participants |
| Region of Enrollment Philippines | 6 Participants |
| Region of Enrollment Poland | 11 Participants |
| Region of Enrollment Romania | 5 Participants |
| Region of Enrollment Russia | 0 Participants |
| Region of Enrollment South Africa | 0 Participants |
| Region of Enrollment Spain | 2 Participants |
| Region of Enrollment Turkey (Türkiye) | 1 Participants |
| Region of Enrollment Ukraine | 0 Participants |
| Region of Enrollment United States | 16 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 67 | 0 / 66 |
| other Total, other adverse events | 10 / 67 | 9 / 67 | 8 / 66 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 | 0 / 66 |
Outcome results
None listed