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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04469686
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Cristcot HCA LLC
Information provided by (Responsible Party):
Cristcot LLC

Tracking Information
First Submitted Date  ICMJE July 2, 2020
First Posted Date  ICMJE July 14, 2020
Last Update Posted Date July 31, 2020
Estimated Study Start Date  ICMJE July 30, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
Clinical remission measured using the Modified Mayo Score [ Time Frame: 28 days ]
To evaluate the the efficacy of two dosage regimens of the study drug
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
  • Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency [ Time Frame: 28 days ]
    To assess the change in stool frequency
  • Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0 [ Time Frame: 28 days ]
    To assess the change in rectal bleeding
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2020)
  • Quality of Life assessed measured using IBDQ validated questionnaire [ Time Frame: 28 days ]
    To examine the quality of life of patients
  • Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment [ Time Frame: 28 days ]
    To assess disease severity
  • Concentrations of hydrocortisone acetate using pharmacokinetic sampling [ Time Frame: 28 days ]
    To evaluate the exposure of hydrocortisone acetate levels for safety
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Phase 3 Study to Evaluate the Safety and Efficacy of Hydrocortisone Acetate Suppositories
Official Title  ICMJE 3-Arm Randomized Placebo Controlled Double Blind Phase 3 Study to Evaluate Safety and Efficacy of Once-Daily and Twice-Daily Hydrocortisone Acetate 90 mg Suppository Administered With a Sephure Applicator in Subjects With Ulcerative Colitis
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 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 UC of the rectum.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Proctitis
Intervention  ICMJE
  • Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
    Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
    Other Name: Twice Daily - Active
  • Combination Product: Once 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
    Other Name: Once Daily - Active
  • Combination Product: Twice daily placebo suppository administered with Sephure applicator
    Twice daily placebo suppository administered with Sephure applicator
    Other Name: Twice Daily - Placebo
Study Arms  ICMJE
  • Experimental: Twice Daily - Active
    Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator
    Intervention: Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
  • Experimental: Once Daily - Active
    Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator
    Intervention: Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
  • Placebo Comparator: Placebo
    Twice daily placebo suppository administered with Sephure suppository applicator
    Intervention: Combination Product: Twice daily placebo suppository administered with Sephure applicator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 9, 2020)
618
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or non pregnant, non lactating females aged 18 years and older.
  • 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 3-8.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mark C Ensign 978-212-6380 mark.ensign@cristcot.com
Contact: Lead Scientist 978-212-6380 research@cessa-uc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04469686
Other Study ID Numbers  ICMJE CHS1221
2019-003596-19 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cristcot LLC
Study Sponsor  ICMJE Cristcot LLC
Collaborators  ICMJE Cristcot HCA LLC
Investigators  ICMJE Not Provided
PRS Account Cristcot LLC
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP