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

Sponsor
Cristcot LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04469686
Collaborator
Cristcot HCA LLC (Industry)
618
Enrollment
75
Locations
3
Arms
36.7
Anticipated Duration (Months)
8.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
  • Combination Product: Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
  • Combination Product: Twice daily placebo suppository administered with Sephure applicator
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
618 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 10, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Twice Daily - Active

Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure suppository applicator

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 Names:
  • Twice Daily - Active

    		•
    Experimental: Once Daily - Active

    Once daily 90 mg hydrocortisone acetate and once daily placebo suppository administered with Sephure suppository applicator

    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 Names:
  • Once Daily - Active

    		•
    Placebo Comparator: Placebo

    Twice daily placebo suppository administered with Sephure suppository applicator

    Combination Product: Twice daily placebo suppository administered with Sephure applicator
    Twice daily placebo suppository administered with Sephure applicator
    Other Names:
  • Twice Daily - Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical remission measured using the Modified Mayo Score [28 days]

      To evaluate the the efficacy of two dosage regimens of the study drug

    Secondary Outcome Measures

    1. Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency [28 days]

      To assess the change in stool frequency

    2. Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0 [28 days]

      To assess the change in rectal bleeding

    Other Outcome Measures

    1. Quality of Life assessed measured using IBDQ validated questionnaire [28 days]

      To examine the quality of life of patients

    2. Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment [28 days]

      To assess disease severity

    3. Concentrations of hydrocortisone acetate using pharmacokinetic sampling [28 days]

      To evaluate the exposure of hydrocortisone acetate levels for safety

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Research Associates LLC Huntsville Alabama United States 35801
    2 Homestead Associates in Research Miami Florida United States 33032
    3 Rejuvaline Medical Research Miami Florida United States 33155
    4 Ezy Medical Research Miami Florida United States 33175
    5 One Health Research Clinic Atlanta Norcross Georgia United States 30093
    6 Clinical Research Institute of Michigan Chesterfield Michigan United States 48047
    7 Revive Research Institute Royal Oak Michigan United States 48073
    8 Sanmora Bespoke Clinical Research East Orange New Jersey United States 07018
    9 Ohio Gastroenterology & Liver Institute Cincinnati Ohio United States 45219
    10 Great Lakes Gastroenterology Research, LLC Mentor Ohio United States 44060
    11 Gutherie Medical Group, PC Sayre Pennsylvania United States 18840
    12 Allied Digestive Disease Center Cypress Texas United States 77429
    13 Digestive Health Associates Houston Texas United States 77024
    14 Elixir Research Group Houston Texas United States 77077
    15 GI Specialists of Houston Houston Texas United States 77346
    16 Dr. Jignesh P. Shah Pearland Texas United States 77584
    17 Southern Star Research Institute San Antonio Texas United States 78229
    18 Spring Gastroenterology Associates Spring Texas United States 77379
    19 Texas Gastroenterology Associates (A1 Clinical) Spring Texas United States 77386
    20 Velocity Clinical Research/Gut Whisperer West Jordan Utah United States 84065
    21 Praxis Dr. Michael R. Mross Berlin Germany 10318
    22 Studiengesellschaft BSF UG Halle Germany 06108
    23 EuGastro GmbH Leipzig Germany 04103
    24 Gastro Campus Research GbR Münster Germany 48159
    25 Zentrum für Gastroenterologie Saar MVZ GmbH Saarbrücken Germany 66111
    26 Humanity & Health Clinical Trial Centre Hong Kong Hong Kong
    27 Queen Mary Hospital Hong Kong Hong Kong
    28 Pushpawati Singhania Research Institute New Delhi Delhi India 110017
    29 Ahmedabad Bariatrics & Cosmetics Private Limited (Asian Bariatrics) Ahmedabad Gujarat India 380051
    30 Sanjivani Superspeciality Hospital Ahmedabad Gujarat India 38051
    31 Midas Institute of Gastroenterology Nagpur Maharashtra India 440010
    32 .J Medical Collegue and Season General Hospital Pune Maharashtra India 411001
    33 Ashwin Medical Foundation Multispeciality Hospital Pune Maharashtra India 411033
    34 Acharya Vinoba Bhave Rural Hospital Wardha Maharashtra India 442004
    35 Max Smart Super Speciality Hospital Saket New Delhi India 100017
    36 SMS Medical College & Hospital Jaipur Rajasthan India 302004
    37 SIMS Hospital Chennai Tamilnadu India 600026
    38 Ospedale: Azienda Policlinico Universitario Bari Bari Italy 70124
    39 Università di Cagliari, Dipartimento di Scienze mediche e sanità pubblica Cagliari Italy 09042
    40 University della Campania 'Luigi Vanvitelli' Napoli Italy 80138
    41 Hospital da Padova Padova Italy 35128
    42 A.O. Ordine Mauriziano di Torino Torino Italy 10128
    43 Cebu Doctors' University Hospital Cebu City Cebu Philippines 6000
    44 The Medical City Iloilo Iloilo City Iloilo Philippines 5000
    45 West Visayas State University Medical Center Iloilo City Iloilo Philippines 5000
    46 Makati Medical Center Makati City Metro Manila Philippines 1229
    47 National Kidney and Transplant Institute Quezon City Metro Manila Philippines 1101
    48 St. Luke's Medical Center Quezon City Metro Manila Philippines 1112
    49 Cardinal Santos Medical Center (CSMC) San Juan Metro Manila Philippines 1502
    50 The Medical City Clark Mabalacat Pampanga Philippines 2023
    51 Manila Doctors Hospital Manila Philippines 1000
    52 The Medical City Ortigas Manila Philippines 1605
    53 Uromed Jakub Koteras Twoja Przychodnia- Szczecińskie Centrum Medyczne Szczecin Zachodniopomorskie Poland 71434
    54 Vitamed Galaj i Cichomski Sp.j. Bydgoszcz Poland 85079
    55 Osrodek Badan Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak, Malgorzata Trzaska Bydgoszcz Poland 85794
    56 Centrum Medyczne Lukamed Joanna Luka Wendrowska Chojnice Poland 89600
    57 Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o Jelenia Góra Poland 58500
    58 Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. Ksawerów Poland 95054
    59 Twoja Przychodnia - Centrum Medyczne Nowa Sol Nowa Sól Poland 67100
    60 Korczowski Bartosz, Gabinet Lekarski Rzeszów Poland 35-302
    61 Sonomed Sp. z o.o. Szczecin Poland 71685
    62 WIP Warsaw IBD Point Prof. Kierkus Warszawa Poland 00728
    63 Medical Concierge Centrum Medyczne Warszawa Poland 02798
    64 Melita Medical Centrum Medyczne Wrocław Poland 50449
    65 Spitalul Clinic Colentina Bucharest Romania 020125
    66 Spitalul Clinic 'Dr Ion Cantacuzino' Bucharest Romania 020475
    67 IC Fundeni 2 Gastro enterology department Bucharest Romania 022328
    68 Spitalul Universitar de Urgenta Bucuresti Bucharest Romania 050098
    69 Hospital Virgen de la Salud Toledo Castilla La-Mancha Spain 45004
    70 Hospital Dr. Negrín Las Palmas De Gran Canaria Islas Canarias Spain 35010
    71 Hospital Universitario de Fuenlabrada Fuenlabrada Madrid Spain 28942
    72 Hospital La Princesa Madrid Spain 28006
    73 Hospital Clinico San Carlos and Instituto de Investigacion del Hospital Clinico San Carlos Madrid Spain 28040
    74 National Pirogov Memorial Medical University, Vinnytsya Vinnytsia Vinnytsya Region Ukraine 21028
    75 National Pirogov Memorial Medical University Vinnytsya Vinnytsia Vinnytsya Region Ukraine 21029

    Sponsors and Collaborators

    • Cristcot LLC
    • Cristcot HCA LLC

    Investigators

    • Study Director: Ade Adeboye, MD, Cristcot LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Cristcot LLC
    ClinicalTrials.gov Identifier:
    NCT04469686
    Other Study ID Numbers:
    • CHS1221
    • 2019-003596-19
    First Posted:
    Jul 14, 2020
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Proctitis
    Ulcer
    Hydrocortisone
    Hydrocortisone 17-butyrate 21-propionate
    Hydrocortisone acetate
    Hydrocortisone hemisuccinate

    Study Results

    No Results Posted as of Aug 18, 2022