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

Ulcerative Proctitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469686
• Other study ID #: CHS1221
• Secondary ID: 2019-003596-19
• Status: Recruiting
• Phase: Phase 3
• Start date: December 10, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Cristcot LLC
• Contact: Mark C Ensign
• Phone: 978-212-6380
• Email: mark.ensign[@]cristcot.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 618
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Proctitis
• Ulcer
• Ulcerative Proctitis

Intervention

Combination Product:
• Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
• 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
• Twice daily placebo suppository administered with Sephure applicator
Twice daily placebo suppository administered with Sephure applicator

Locations

Country	Name	City	State
Bulgaria	Hospital Sveti Panteleimon	Plovdiv
Bulgaria	Medical Center Hipokrat - H	Plovdiv
Bulgaria	LTD Diagnostic Consultative Center 1	Sliven
Bulgaria	Medical Center Excelsior	Sofia
Bulgaria	Medical Center Excelsior 2	Sofia
Denmark	Aalborg University Hospital	Aalborg
Denmark	Hvidovre Hospital	Hvidovre
Denmark	Zealand University Hospital	Køge
France	CHU Tours - Service d'hepato-Gastro-enterologie	Chambray-lès-Tours
France	CHU Lille - Hopital Claude Huriez	Lille
France	CHU Montpellier - Hopital Saint Eloi	Montpellier
France	Hopital Lyon Sud - HCL	Pierre-Bénite
France	CHU de Saint-Etienne	Saint-Priest-en-Jarez
France	Hopital Rangueil	Toulouse
Georgia	JSC Vian	Kutaisi
Georgia	LTD "Multi-Profile Clinic Consilium Medulla"	Tbilisi
Georgia	LTD Aversi Clinic	Tbilisi
Georgia	Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic	Tbilisi
India	SMS Medical College & Hospital	Jaipur	Rajasthan
India	Acharya Vinoba Bhave Rural Hospital	Wardha	Maharashtra
Jordan	Al Khalidi Hospital and Medical Center	Amman
Jordan	Istiklal Hospital	Amman
Jordan	Istishari Hospital	Amman
Jordan	Jordan University Hospital	Amman
Jordan	The Specialty Hospital Advanced Clinical Center	Amman
Jordan	Irbid Specialty Hospital / Clinical Research Center	Irbid
Jordan	Pharmaceutical Research Center / Jordan University of Science and Technology	Irbid
Lebanon	Dr. Bilal Hotayt Gastroenterology	Beirut
Lebanon	Saint George Hospital University Medical Center	Beirut
Lebanon	Hammoud Hospital University Medical Center	Sidon
Lebanon	Nini Hospital	Tripoli
Moldova, Republic of	Institutul de Cardiologie Consultative Department, RTL Clinic	Chisinau
Moldova, Republic of	Republican Hospital Timofei Mo?neaga Consultative Department Policlinic	Chisinau
Philippines	West Visayas State University Medical Center	Iloilo City	Iloilo
Philippines	The Medical City Clark	Mabalacat	Pampanga
Philippines	Makati Medical Center	Makati City	Metro Manila
Philippines	The Medical City Ortigas	Pasig	Manila
Philippines	St. Luke's Medical Center	Quezon City	Metro Manila
Poland	Centrum Medyczne Lukamed Joanna Luka Wendrowska	Chojnice
Poland	Centrum Medyczne MBB-MED	Chrzanów
Poland	Centrum Medyczne CLW-MED	Grudziadz
Poland	Karkonoskie Centrum Badan Klinicznych Lexmedica Sp. z o.o	Jelenia Góra
Poland	Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.	Ksawerów
Poland	AMICARE Sp. z o.o. sp. k.	Lódz
Poland	Uromed Jakub Koteras Twoja Przychodnia- Szczecinskie Centrum Medyczne	Szczecin	Zachodniopomorskie
Poland	Medical Concierge Centrum Medyczne	Warszawa
Poland	Medical Network Spólka z o.o.	Warszawa
Poland	Melita Medical Centrum Medyczne	Wroclaw
Romania	Clinical Institute Fundeni Gastroenterology Department No. 2	Bucharest
Romania	Spitalul Clinic Colentina	Bucharest
Romania	Regional Institute of Gastroenterology and Hepatology	Cluj-Napoca
Romania	Gastromedical SRL	Iasi
Romania	Tirgu-Mures Country Clinical Hospital	Târgu-Mures
Romania	Centrul de Gastroenterologie Dr. Goldis	Timisoara
Saudi Arabia	King Abdulaziz University Hospital	Jeddah
Saudi Arabia	National Guard Hospital Jeddah	Jeddah
Saudi Arabia	King Fahad Medical City	Riyadh
Saudi Arabia	King Khalid University Hospital	Riyadh
Saudi Arabia	National Guard Hospital Riyadh	Riyadh
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Inspired GI Care	Cape Town	Western Cape
South Africa	Wits Clinical Research	Johannesburg	Gauteng
South Africa	EMMED	Pretoria
Turkey	SBÜ. Antalya Egirim ve Arastirma Hastanesi Gastroenteroloji	Antalya
Turkey	Marmara Universitesi Pendik Egitim Arastirma Hastanesi Gastroenteroloji	Istanbul
Turkey	Ege Universitesi Tip Fakultesi Hastanesi Gastroenteroloji	Izmir
Turkey	Mersin Universitesi Tip Fakultesi Gastroenteroloji	Mersin
Turkey	Karadeniz Teknik Üniversitesi Tip Fakütesi Hastanesi Gastroenteroloji	Trabzon
United States	Om Research	Apple Valley	California
United States	Om Research	Camarillo	California
United States	Westchester Putnam Gastro	Carmel	New York
United States	Clinical Research Institute of Michigan LLC	Chesterfield	Michigan
United States	Gastro Health Research	Cincinnati	Ohio
United States	Gastro Associates of Greenville	Greenville	South Carolina
United States	Susquehanna Research Group, LLC	Harrisburg	Pennsylvania
United States	Dr. Mouhamed Al-Sabbagh	Houston	Texas
United States	Clinical Research Associates LLC	Huntsville	Alabama
United States	Tri-Cities Gastroenterology	Kingsport	Tennessee
United States	Combined Gastro LLC	Lafayette	Louisiana
United States	Om Research	Lancaster	California
United States	NexGen Research	Lima	Ohio
United States	Southern CA Research Institute Medical Group	Los Angeles	California
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Gastro Health Research of Miami	Miami	Florida
United States	GI PROs Research	Naples	Florida
United States	Comprehensive Gastrointestinal Health LLC	Northbrook	Illinois
United States	California Medical Research Associates Inc	Northridge	California
United States	Gastroenterology of Greater Orlando	Orange City	Florida
United States	Revival Clinical Research	Orlando	Florida
United States	Southern Star Research Institute	San Antonio	Texas
United States	Clinical Applications Laboratories	San Diego	California
United States	Medrasa Clinical	Sherman	Texas
United States	International Center for Research	Tampa	Florida
United States	Clinical Research Institute of Michigan	Troy	Michigan
Vietnam	103 Military Hospital	Hanoi
Vietnam	Bach Mai Hospital	Hanoi
Vietnam	Hanoi Medical University Hospital	Hanoi
Vietnam	Viet Duc Hospital	Hanoi
Vietnam	Vinmec Hospital	Hanoi
Vietnam	115 People's Hospital	Ho Chi Minh City
Vietnam	Cho Ray Hospital	Ho Chi Minh City
Vietnam	Gia Dinh People's Hospital	Ho Chi Minh City
Vietnam	Nguyen Tri Phuong Hospital	Ho Chi Minh City
Vietnam	Hue Central Hospital	Hu?

Sponsors (2)

Lead Sponsor	Collaborator
Cristcot LLC	Cristcot HCA LLC

Countries where clinical trial is conducted

United States,  Vietnam,  Bulgaria,  Denmark,  France,  Georgia,  India,  Jordan,  Lebanon,  Moldova, Republic of,  Philippines,  Poland,  Romania,  Saudi Arabia,  South Africa,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life assessed measured using IBDQ validated questionnaire	To examine the quality of life of patients	28 days
Other	Grading of disease severity measure using Mayo Scoring sub-score of Physician's Global Assessment	To assess disease severity	28 days
Other	Concentrations of hydrocortisone acetate using pharmacokinetic sampling	To evaluate the exposure of hydrocortisone acetate levels for safety	28 days
Primary	Clinical remission measured using the Modified Mayo Score	To evaluate the the efficacy of two dosage regimens of the study drug	28 days
Secondary	Reduction of stool frequency measured using Mayo Scoring sub score of stool frequency	To assess the change in stool frequency	28 days
Secondary	Rectal bleeding measured using Mayo Scoring sub-score of rectal bleeding equal to 0	To assess the change in rectal bleeding	28 days

External Links

•   A clinical study to evaluate the safety and effectiveness of an investigational hydrocortisone acetate 90 mg suppository administered with the Sephure applicator for the treatment of moderate to severe ulcerative colitis